THE ORKAND CORPORATION
DATA MANAGEMENT
CENTRAL OFFICE
STANDARD OPERATING PROCEDURES
November 22, 1996
Version 1.2
Introduction 1Routine duties of the Central Office include: 1Randomization/Registration of Patients 1Process for Receiving Telephone Registrations 1Medicine or Clinical Pharmacology Branch Telephone Registrations 2Surgery, Radiation Oncology and Metabolism Telephone Registrations 3Navy Medical Oncology Branch Telephone Registrations 3Compassionate Exemptions 4Process for Receiving Telephone Registrations for the VENOUS ACCESS DEVICE STUDY 5Process for Receiving FAXED Registrations 5Randomizations 6Process for Receiving Telephone Randomizations 6Medicine or Clinical Pharmacology Surgery, Navy and Pediatric Telephone Randomizations 6Surgery Branch Weekend Randomizations 7Preparation of Eligibility Checklists 8Maintenance of the Registration Books 9Procedure for Protocol Closed to Accrual 9Procedure for Terminated Protocols 9Procedure for Running "BLANK" Queries 10Monitoring Patient Accrual 10Protocols Reaching Maximum Accrual 10Preparing Computerized Randomizations 11Introduction 11Randomization Criteria 11Setting Up a New Randomization Program 12Output 17Requests to Increase Patient Accrual 18Protocol Management 18Maintaining Files 19Open Protocols 19Closed Protocols 19Terminated Protocols 19Updating Amended Protocols 19Data Vault Procedures 20Filling Requests for Information 22Routine Reports 24Venous Access Device Report 24Weekly Reports 24All Patients Registered to DCS 24All New Patients Registered to the DCS 25Enrollment Status Report 25Monthly Reports 26MB/CPB Report sorted by Onstudy for Dianne Reeves 26Randomization Log 26Radiation Registration Report 26Pediatric Branch Protocol Status Report for Dorie Marshall 26Navy Protocol Accrual Report 30Navy Cumulative Reports Sorted by Protocol/Onstudy 31IRB Report 33Quarterly Reports 34Quarterly Report Selection Criteria 34Accrual Status Report 34Quarterly Protocol Accrual Summary Report 35AMGEN Report 35Maryland State Registry 36CDR MAINTENANCE 38CDR Branch Connection Procedures 38Medicine and Clinical Pharmacology Branches 39Radiation Oncology Branch 39Surgery Branch 39Data Entry 39Edit and Quality Assurance Procedures 39Backing up the Clinical Data Registry 40
The Central Office provides data management support for the National Cancer Institute Division of Clinical Sciences (DCS). Support includes registering and randomizing patients on protocols, preparing protocol eligibility checklists, generating routine and ad hoc reports concerning protocol activity and patients status, and data entry and quality control of the Clinical Data Registry (CDR). The nature of the duties of the central office does not involve direct patient contact but is focused on managing confidential patient information that is used by researchers to develop new treatments for patients with cancer and/or HIV infection. In order to effectively support the clinical research process, the data that is collected and tracked must be accurate and complete in order to produce valid reports for researchers to effectively manage safe health care for patients as well as answer clinical research questions.
Randomization/registration of all DCS patients
Preparing eligibility checklists
Maintaining Registration Books
Monitoring patient accrual
Preparing stratification for randomized protocols
Preparing routine and ad hoc reports
Maintaining the Clinical Data Registry System
Protocol Tracking
Maintaining Data Vault
The randomization and registration process ensures that each patient has legally consented to participate in a study and has met all of the eligibility criteria of the protocol. All DCS patients must be registered on active protocols. Checklists are kept in binders which are arranged by protocol number and separated by branch. Each protocol is preceded by a log sheet, then the checklists of registered patients, followed by blank forms.
ALL PATIENTS MUST BE REGISTERED ON ACTIVE PROTOCOLS.
There are two dedicated lines, 402-1732 and 402-1733, for receiving telephone registrations during working hours: 8:30a.m. to 5:00p.m., Monday through Friday. (If the caller wants to register a patient, continue here. If they ask to "RANDOMIZE" a patient, go to section "B". If they want to register a patient on the "VAD" (Venous Access Device) study, go to section "C").
NOTE: Medicine, Clinical Pharmacology, Radiation and Surgery registration information is electronically transferred from the branches to CDR at the beginning of the month and thus not entered directly into CDR as it is done for Navy registrations.
Ask if the patient is a Compassionate Exemption.
The procedure for Compassionate Exemption is as follows:
If none of the above conditions apply, ask if the Principal Investigator has approved the patient. If so, proceed and write "P.I. approved" beside the question. If any lab results have not been returned, do not proceed. Ask the caller to call back when the results have returned.
Registrations for this study are received either through the telephone or the fax. The telephone registrations are taken from the Research Nurses in either the Medicine or Clinical Pharmacology Branches. These nurses will generally only registered any patient who has received a PICC line. The faxed registrations are received from Cathy Parker a Nurse in the Day Hospital. Cathy will generally register all other types of VADs.
The procedure for taking telephone registrations is as follows: (VAD PICC lines)
Any and all handwritten additions and corrections made to the VAD information are entered onto the WordPerfect document titled VAD.LAN as necessary and only those pages with updates and or changes are faxed to Dianne Reeves as necessary.
The procedure for taking telephone registrations is as follows: (All other VAD)
NOTE: Patients that have been previously entered must not receive a new number, but should be registered.
Process for receiving FAXED registrations - Dermatology, Metabolism, Navy, Pediatric, and Radiation Branches and some Surgery Branch Nurses will register their patients using FAXES.
Randomizing a patient is similar to registering a patient on a protocol. The only difference is determining which treatment the patient will receive by asking the stratification questions. Most calls for randomizations are for Surgery Branch protocols.
This procedure is only for patients who are expected to begin treatment on the weekend. Either Claudia Seipp or Jan Einhorn will call and say that they need a weekend randomization and to give the regimen to either Melissa Corbitt or Allison Wise.
Follow the normal procedures for randomization, however, make sure to write everything in pencil:
1. Ask the biographical information and complete all information in pencil.
- Patient name, Hospital number, etc.
2. Ask the eligibility questions.
3. Determine which treatment or regimen the patient will get by asking the stratification question(s).
4. Put the caller on hold.
5. Do not give the treatment to the doctor, nurse, etc....
6. Write the patient's name in pencil in the treatment box and circle the treatment in pencil on the checklist.
7. Tell only Melissa or Allison what regimen the patient will be given and they will put it in a sealed envelope and put it in the doctor's box.
8. Let the other Data Managers in the Central Office know that a weekend randomization has been done and the onstudy date will be verified on Monday.
9. If the Nurse or Data Manager has not called by Monday to verify that the patient went onstudy, the call has to be made by someone in the Central Office. If the patient did start the protocol, all of the information that has been written in pencil must be rewritten in ink. If the patient did not start the protocol, put the checklist in the burn box and erase all information pertaining to that patient. The sealed envelope will be discarded by the registrar.
Eligibility criteria are established by the researchers to determine if patients are medically and/or psychologically able to be enrolled on a protocol. The role of the central office is to prepare a series of questions based on the eligibility criteria for the protocol. Eligibility checklists are prepared for Medicine, Clinical Pharmacology, Navy Medical Oncology, Radiation and Surgery Branch protocols. This activity is usually initiated when the protocol is received from NCI branch personnel. Any CTEP sponsored protocol received from either Jane Cassidy or Janet Dorenberg is a priority and clearly states so on the face sheet. Checklists are prepared on a priority basis.
Registration books are updated when the Central Office receives new or amended protocols, and protocols that have been closed or terminated. The Eligibility Checklists are maintained in Word Perfect.
(All queries are run in CDR)
Patient accrual to open protocols is monitored on an ongoing basis. Protocol ceilings are documented in the registration books at the top of each summary sheet for all protocols.
Each DCS protocol has a maximum number of patients that will be accrued. The Data Manager must monitor the log sheet for the number of patients enrolled. As the maximum accrual is being approached (i.e., two (2) patients under the accrual ceiling) a memorandum (Exhibit E) must be sent to the Principal Investigator of the protocol. The accrual total does not include EXEMPTIONS. Copy the memorandum on Orkand stationary and send two (2) originals to Jane Cassidy and one (1) copy to Dianne Reeves (for MB and CPB). One original is put in the Official IRB file by Jane Cassidy and the other is given to the Principal Investigator. For Radiation and Navy, a copy of the letter is sent to the respective Research Nurses. The copy of the memorandum that is retained in the Central Office is filed in the protocol folder located in the Current Protocols filing cabinet. Patients will not be registered on protocols above the accrual ceiling until the protocol has been amended.
In order to conduct a randomized clinical trial, there must be some method of randomly assigning patients to treatments as they become eligible for the study (or the randomized portion of the study). Randomization prevents the bias of the patient or doctor from influencing the study results. The patient is selected by chance to be on an arm.
One such method is for a series of envelopes to be prepared ahead of time, in decks according to the study stratification variables. Within these envelopes are placed cards containing the treatment assignment. Within each deck, the treatments are derived randomly, subject to the restriction that after a certain number of cards in the deck, the treatment assignments will be balanced. The program described on the following pages will produce a label that is placed on the envelope to identify the study and the deck, and a label that identifies the treatment assignment which is inserted into the envelope.
Another method is to use a list, which may be considered the equivalent of a sealed envelope.
This program produces lists, labels or lists and labels. The documentation which follows usually refers to labels, rather than lists, since the program was originally developed to produce labels.
A change made to the program ensures that the first treatment assignments will be balanced over all decks or lists, i.e. there is no possibility that all or most of the first assignments will be the same.
You will receive a request for contract computing and data management support from Seth Steinberg to produce a randomization program. The following criteria to structure the randomization are written on the work request:
CRITERIA EXAMPLE
RANDOMIZATION
| Study number | 91-C-0120 | ||
| Long title | .................. | ||
| Short title | ........ | ||
| Treatment arm | Pentox/Thiotepa | OR | Regimen #1 |
| Stratification | Doxorubicin PSA Less Than 100 PSA 100 - 500 PSA Greater Than 500 | OR | Regimen #2 Deck/list #1 Deck/list #2 Deck/list #3 |
| Number of Patients per list | 48 | ||
| Accrual | 74 | ||
| Block size | 4 | ||
| Weight (may be given) |
standard ratio is 1:1 if not otherwise specified
Log on to WYLBUR
All of the previous randomization programs are saved in a partitioned dataset: &NCPCJAG.RAND.LIB ON FILE
Use an existing dataset to structure and create the new program:
- copy the dataset into a new file and save it with the name of the new protocol
- lines 1/14 are standard JCL
The JCL must be in every program
Modify line 2 only to correspond to the name and date of the new program. Save as a partitioned dataset according to the study number.
The first line entered is the `X' card which indicates to the program the number of sets(runs) that are to be produced.
COLUMN(S) CHARACTER(S) FORMAT CODE
| 1 | 1 | A | X = X card |
| 3-4 | 2 | NN | 01 - 99 (range) 01 - 1 copy of lists/labels or decks |
| 6 | 1 | ` ` | Blank = to print study #, deck #, tx assignment on labels |
Example Line: 15. x 01
NOTE:
1. Right justify column 3-4 or enter a zero in front of the number.
`A' CARD
Enter the following on card `A'
- Protocol number
- Number of treatment arms
- Number of decks
- Block size
- List indicator
- Protocol name
COLUMN(S) CHARACTER(S) FORMAT CODE
| 1 | 1 | A | A =A card |
| 3-10 | 8 | NN-C-NNN | study number |
| 12 | 1 | N | 2 = two tx arms 3 = three tx arms 4 = four tx arms 5 = five tx arms 6 = six tx arms 7 = seven tx arms 8 = eight tx arms 9 = nine tx arms |
| 13-15 | 3 | NNN | 01-999 (range) i.e. 01 = # of decks or lists The number of stratification variables |
| 17-18 | 2 | NN | NN = block size |
| 20 | 1 | N | 1 = labels 2 = lists 3 = labels and lists |
| 22 | 1 | N | 1 = labels for selected decks ` ' = labels for all decks |
24 The format to be used for the columns of any lists. The code indicates both the column headings and the data to be printed for each column.
COLUMN(S) CHARACTER(S) FORMAT CODE
Available formats:
An asterisk (*) preceding the name of the column indicates that the column will contain entries generated by this program.
CODE COLUMNS
Blank *Sequence number, *assigned treatment,
or zero patient name, randomization date.
26-23 38 text protocol name
EXAMPLE LINE: 16. a 91-C-120 2 03 04 2 Pentox/Thiotepa vs. Doxoru
NOTES:
1. Right justify column 14-15.
2. Right justify column 17-18.
3. Leave column 22 blank if labels are needed for all decks.
4. Enter a `1' in column 22 for labels to be produced for selected decks.
`B' CARD
A `B' card is required for each treatment
Enter the following on card B:
- Treatment number
- Treatment weight
- Treatment name
COLUMN(S) CHARACTER(S) FORMAT CODE
| 1 | 1 | A | B = B CARD |
| 3 | 1 | N | 1 = Tx. 1 2 = Tx. 2 3 = Tx. 3 4 = Tx. 4 5 = Tx. 5 6 = Tx. 6 7 = Tx. 7 8 = Tx. 8 9 = Tx. 9 |
| 5-6 | 2 | NN | 01-99 (range) |
| 8-45 | 20 | text | Tx. name |
EXAMPLE LINE: 17. B 1 01 Pentox. and Thiotepa
18. B 2 01 Doxorubicin
NOTES:
1. The weight is a 1:1 unless otherwise specified and must be > 0.
2. The treatment name can only be 20 characters for lists.
`C' CARD
A `C' card is required for each treatment.
Enter the following on the C card:
- Deck number
- Deck to be printed
- The number of cards required/pts. per list
- Initial sequence number
- Selection indicator
COLUMN(S) CHARACTER(S) FORMAT CODE
| 1 | 3 | A | C = C record |
| 3-4 | 2 | NN | 01 - 99 (range) i.e. 01 = deck/ list number |
| 6-7 | 2 | NN | 01 - 99 (range) i.e. 01 = corresponding # of the deck/list to be printed always the same as column 3-4 |
| 8-10 | 3 | NNN | # cards/pts per list |
| 11-13 | 2 | NN | sequence number |
| 15 | 1 | N | 1 = labels |
| `blank' |
EXAMPLE LINE: 19. C 01 01 48 01
NOTE:
1. Right justify columns 6-7, 9-10, 12-13
Position #15 `blank' - if position 22 of the `A' card contains a `1', labels will not be produced for this deck.
`D' CARD
A `D' card is required for each treatment.
Enter the following on the D card:
- Deck/list number
- First line of the deck/list name
COLUMN(S) CHARACTER(S) FORMAT CODE
| 1 | 1 | A | D = D card |
| 3-4 | 2 | NN | 01 - 99 (range) |
| 6-43 | 38 | text | deck/list name |
EXAMPLE LINE: 20. D 01 PSA Less Than 100
NOTE:
1. Right justify column 3-4
`E' CARD
Enter the following on the C card:
- Deck/list number
- Second line of deck/list name
COLUMN(S) CHARACTER(S) FORMAT CODE
| 1 | 1 | A | E = E record |
| 3-4 | 2 | NN | 01 - 99 (range) |
| 6-43 | 38 | text |
EXAMPLE LINE: 21. E 01
The entire program should look like this for lists:
15. X 01
16. A 91-C-120 2 03 04 2 Pentox/Thiotepa vs. Doxorubicin
17. B 1 02 Pentox. and Thiotepa
18. B 2 02 Doxorubicin
19. C 01 01 48 01
20. D 01 PSA Less Than 100
21. E 01
22. C 02 02 48 01
23. D 02 PSA 100 - 500
24. E 02
25. C 03 03 48 01
26. D 03 PSA Greater Than 500
27. E 03
After all of the lines have been collected or modified, save the data set. Subsequent runs for additional labels or lists only require modification of the data set.
1. Listing of the input data. The program edits all input data. Depending on the type of error detected, the input data listing may or may not be complete. If there are any errors in the input data, labels will not be produced. The error messages will be printed relatively close to the input data that is incorrect. Each error message is preceded by the characters `<+>'. If you use the RUN HOLD command for the job and the FETCH it command to see the job, a search for this character string will indicate quickly whether the job ran successfully. The list output of the run should be filed with the completed randomization request in the appropriate file, Medicine Branch, POB, Surgery Branch, or Other.
2. Randomization labels (if requested) are produced via SPOUT, if no errors are detected in the parameters.The labels are printed three across the page. The left-most label in the row is placed on the randomization envelope and contains the protocol number, deck number, sequence number, protocol name, and deck name. The middle label is placed on the randomization card and contains the protocol number, deck number, sequence number, and the assigned treatment. The right-most label is not used.
3. Randomization lists (if requested) will be produced on 999 (8 1/2 x 11) paper which may be used to assign treatments and record the randomization activity. Lists are the most requested form of randomization that is received.
If at anytime the accrual lists need additional treatment assignments select the "C" card of the treatment that needs the accrual increased. The program was not designed to increase the sequence number to allow for a running list.
- col 8-10 enter the # of patients
- col 11-13 enter the # 1, this never changes
i.e. The last sequence number was 25.
A request to increase the accrual to 50 patients is submitted.
Card "C" should be entered as follows:
C 01 01 50 1
Run the program as usual.
After you have received the list(s) "X" out the lines that are not needed and continue with the next sequence.
i.e. "X" out 1/25 and begin at sequence 26 when assigning treatments.
There are important tasks that must be done in order to track protocols: maintaining files including open protocols, closed protocols and terminated protocols, modify eligibility checklists to include amendments and informing the Principal Investigator when the protocol is about to reach maximum accrual.
Information that must be in protocol files:
1) Initial Review Application
2) Draft of eligibility criteria
3) Approved eligibility criteria
4) Maximum accrual memoranda
5) Protocol amendments
6) Miscellaneous memoranda
7) Closed protocol application
8) Terminated protocol application
When the status of a protocol changes, do not make a new folder, just transfer the file to the appropriate cabinet.
FILING - there are separate file cabinets for open, closed, and terminated protocols
Open protocols are currently accruing patients on the study. These protocols are filed in the cabinet labeled "Current Protocols."
Closed protocols are no longer accruing patients on the study but follow-up is continued. These protocols are filed in the cabinet drawer labeled "Closed Protocols." The protocol logs will delineate the status of each protocol and can be used as a cross reference guide. Within the cabinet the open and closed protocols are filed mainly by the Branch Number i.e. MB313, in ascending order. The Navy branch protocols are filed in order of a four digit branch number i.e. 93-10. All other branches are filed in order of the CC number. Terminated protocols are filed in cabinets labeled "Terminated Protocols." These protocols are filed only by the clinical center number in ascending order.
Patients are continuously being enrolled on open protocols until there is enough data collected on the patients to statistically evaluate the study drug(s). The Data Management section monitors the accrual rate of all patients and submits lists to the Branches and the Project Offices.
As the continuing review application indicating that the protocol is "Renew - Enroll Subject Follow-up Only" is received the eligibility criteria and the Summary Sheets are pulled from the books and put in the file folder. The file is transfered to the file drawer(s) marked closed protocols.
Activity of these protocols are discontinued and filed in the file cabinet labeled terminated protocols. The Central office is given a list by the Biostatistics secretary of terminated protocols. The secretary will give the Data Manager the file containing all of the protocol's information. Insert the list in the black notebook labeled Master Listings of Protocols and put the outdated list in the burn box.
Amendments of protocols are given to the Central Office by the Biostatistics secretary. The purpose for the amendments is for corrections or additions to the protocol. The Central Office Staff must read the amendment for corrections to the inclusion and exclusion criteria and patient accrual. If corrections are needed, make the necessary update to the eligibility criteria. Patient accrual may be extended or discontinued. In the case of extending accrual, cross out the old accrual number on the Protocol log and write the new number. The change in the accrual number must also be entered in CDR into the Protocol Lookup table. When patient accrual is discontinued follow the procedures for closed or terminated protocols.
NOTE: When patient accrual is extended, each accrual status list must be changed to reflect the Total Allowed and Over/Under field to concur with the amendment.
The Data Vault located at the McKinley Street Central Office is utilized to store backup media of all clincial data for Surgery, Naval Medical Oncology, Medicine, Clinical Pharmocology, Pediatric, Metabolism, Radition Branches and the Clinial Data Registry System. At the beginning of each month a letter regarding the backups of the individual branches data is sent to the branch representative. As the tapes are received, on a weekly, biweekly or monthly basis the Data Vault log as shown on the following page is updated in Microsoft Word and maintained under the file name - C:\MSWord\OPERATIN. An updated copy of the log is sent to Jane Cassidy and a hard copy is retained in the Data Vault.
DATA VAULT INVENTORY (OPERATING SYSTEMS DATA & DOCUMENTATION)
| SURGERY | DATE | DATE | DATE | DATE |
| Weekly Back up Tapes Immunotherapy | ||||
| NAVY | ||||
| PDMS Back up Tape | ||||
| Monthly Back up Tape | ||||
| MEDICINE & CPB | ||||
| Backup Tapes (Monthly) | ||||
| PDMS Doc Diskette - Users | ||||
| Program System Back up | ||||
| METABOLISM | ||||
| Back up Diskettes (Monthly) | ||||
| PEDIATRIC | ||||
| Rainbow/Server | ||||
| Star Server/User's Workstations | ||||
| RADIATION | ||||
| Radiation Back up | ||||
| CDR | ||||
| CDR Back up Tape | ||||
| CDR Documentation ver 1.1 | ||||
| CDR System Doc (Diskette) | ||||
| PC'S AT THE HOUSE | ||||
| Cert of Authenticity | ||||
| Microsoft Excel License Card | ||||
| Wordperfect Installation Disk | ||||
| Microsoft Excel | ||||
| BACK UP JANET'S PC | ||||
| NCI PROGRESS REPORT DISK |
The purpose for the attached form is to ensure that all information released from the Central Office to a requestor is done to assure strict confidentiality. The identity of all persons requesting information from the Central Office will be verified. Requested information must receive approval prior to being released.
The following procedure outlines the mandatory steps needed in order to expedite the release of any information.
1) Contact Jane Cassidy at 496-4251 or any member of the Central Office at 496-1732 to obtain a Release of Information form. The form will be sent either via fax or courier.
2) Please completely fill out all requester identification and provide as much detail for the description as possible. If you are uncertain of the type of report that will best display the information, call the Central Office and possible reporting formats will be discussed with you.
3) Prior approval must be obtained before any information will be released. Single-level approval will usually be acceptable and can be done by the onsite Orkand Project Manager or Deputy Project Manager. In other cases it may also require approval by Jane Cassidy and at her discretion, approval by the Principal Investigator of the study involved.
4) Please state the level of priority or any deadline if applicable.
Name: ______________________________ NCI Branch: ____________________________
(When applicable)
Phone #: ________________________ Protocol #:______________________________
Fax #: __________________________ Pager #:________________________________
Address:
Bldg.. # _________ Room # __________ Date Requested ___________________
Date Due ____________________
Detailed description of information requested:
Date Received __________________
Completed By ___________________ Date Completed ________________
Priority Level: High, Medium, Low, N/A (circle one)
Approval Signatures: 1.) __________________________ (Project Manager, The Orkand Corporation)
2.) __________________________ (Jane Cassidy, R.N.)
An updated report is faxed to Dianne Reeves as patients are registered (fax number 402-1608 or button number 4 on the fax machine at the Central Office). Prior to faxing the report, all hand written additions and changes, that have been recorded in the blue binder labeled "Venous Access Device", are to be entered on the VAD log for the previous week, and an updated report is printed.
The file is accessed on the.
The form will appear on the screen.
This list is a means of tracking all patients registered on COP protocols (APPENDIX IV). Enrollment is tracked from Sunday to Saturday. (i.e. June 5, 1996 - June 11, 1996). The number of patients enrolled for the week can be abstracted from the Faxed registrations from the Pediatric, Metabolism and Dermatology branches and the Registration/Randomization Master Log.
There are six (6) data fields:
NOTE - All patients that have been registered on a DCS protocol, as long as it is either Primary or Supportive, entered onto the report.
Updating the list:
This list is a means of tracking patients that have never been enrolled on an NCI protocol or patients that are "NEW" to the Clinical Center (APPENDIX VII).
This report serves as a means of tracking all patients registered on MB and CPB protocols (APPENDIX E). Enrollment is tracked from Sunday to Saturday. The number of patients enrolled for the week is abstracted from the Registration/Randomization Master Log.
NOTE: The following WYLBUR Reports are printed at the Division of Computer Research and Technology (DCRT). All of the WYLBUR reports are delivered by the courier the following business day.
There are seven (7) data fields:
Updating the list:
NOTE - Exemptions are not included in the TOTAL ENROLLED field or the NEW ACCRUALS field. Exempt patients must be included in the TOTAL COMP/SPE* field.
i.e. - At the "?" type A `MB297'
- The information for MB297 will be on the screen
- Tab over to each field that needs to be updated
- After the line is updated, hit the ENTER key
Continue this process for each protocol that needs to be updated. Resave the file.
This report is maintained on the DELL computer in the Excel application with the file name: MB.PRO. The purpose of this report is to update the Head Research Nurse of the Protocol Office on a monthly basis as to all of the patients registered on either Medicine or Clinical Pharmocology protocols.
This report is maintained on the Wylbur dataset &NCPCCPR.RAND.LOG. To download this dataset onto the Dell computer type get rand.log C:rand.log on the FTP command. At the C:>prompt type edit rand.log. Enter all of the patients that have been randomized on surgery branch protocols for the previous month. To upload the dataset type: send c:\rand.log ran.log at the FTP commmand. In Wylbur, after verifying that ran.log has the most recent patients, delete the &NCPCCPR file by typing scratch &NCPCCPR.RAND.LOG. Rename the ran.log to RAND.LOG and print it by typing list off line/line unn title Rand.log. At the `?' type send a copy to Allison Wise.
This report is maintained in the Wylbur dataset &NCPCCPR.ROB.REG.LIST to download the dataset onto the Dell computer type get rob.reg.list c:rob.reg on the FTP command line. Enter all patients registered on radiation branch protocols for the previous month. To upload the file to Wylbur type: send c:rob.reg rob.reg on the FTP command line. After verifying all patients in rob.reg scratch &NCPCCPR.ROB.REG.LIST from Wylbur. Rename rob.reg to rob.reg.list. To print type: list off unn a copy for Judy Smith, R.N.
Two monthly reports are produced and provided to Dorie Marshall of the Pediatric Branch. These reports, which contain data for the previous calendar month, are distributed on the first Tuesday of each month.
To begin this report you must first enter CDR and access the Utilities option, select Utilities from the Main Menu, as shown on the following page.
Data_Entry Information Reports Utilities Configuration Exit Credits
Include adhoc queries and Mainframe backup.
| MAIN MENU | THE CLINICAL DATA REGISTRY |
| DATA_ENTRY | Edit patient related information and run offline edits |
| INFORMATION | OnLine singlepatient information retrieval. |
| REPORTS | Prepare/Print various patient reports. |
| UTILITIES | Include adhoc queries and Mainframe backup. |
| CONFIGURATION | Include Password, and Lookup table modification |
| EXIT | Exit CDR and return to DOS. |
Currently selected patient ³ None
You will get the following submenu. Each selection will be described in the following section.
Query Mainframe_Backup Branch_Connect
Use the powerful adhoc query system to ask your database any question
| UTILITIES MENU | THE CLINICAL DATA REGISTRY |
| QUERY | Use the Ad Hoc Query and report system. |
| MAINFRAME BACKUP | Create backup files to be uploaded to the |
| mainframe. | |
| BRANCH CONNECT | Upload data sent periodically from |
| different branches. |
Currently selected patient ³ None
To begin the first query, select the PI table. In the Patient Number field, press the [F6] key and then press the [F5] key and [1] to linkages among tables. Checkmark (Ö) fields to be displayed and enter the selection criteria detailed below.
[AltH] List of commands
[F1] Helpandfill
| PI | Patient Number | Institute | Last Name | First Name & MI |
| 1 | NCI | |||
Then press the [F10] key to select the OS table. In the Patient Number field, press the [F5] key and then press the [1] to establish the link. Checkmark (Ö) fields to be displayed and enter selection criteria displayed below; however, modify the date range in the On_Study field to reflect the previous month and change the protocols number in the Protocol field to include only the protocols for which each nurse is responsible.
| OS | Patient Number | Protocol | On Study |
| 1 | 88C0219 | >=08/01/94,<=08/31/94 | |
| Treatment Group | Branch | Disease Type | Eligible? |
| PO | |||
| Randomized? | Primary Site | Disease | BOCR |
| Protocol Type | Treatment Termination | Off Study | Off Study Reason |
Then press the [F10] key to select the FU table. In the Patient Number field, press the [F5] key and then press the [1] to establish the link. Checkmark (Ö) fields to be displayed and enter selection criteria displayed below.
| FU | Patient Number | Disease Type | Contact Date | AD Status | Death |
| 1 | Ö | Ö | |||
Press the [F2] key. The message, Processing query..., will appear on the screen while the system processes the request. After processing the query, an Answer Table is produced. Sort the Answer Table, as described in Chapter 6, using Protocol as the primary sort and On_Study as the secondary sort.
The second monthly report for the PO Branch is similar to the first report. Sample selection criteria are displayed below.
Begin by selecting the PI table. In the Patient Number field, press the [F6] key and then press the [F5] key and [1] to linkages among tables. Checkmark (Ö) fields to be displayed and enter the selection criteria detailed below for the PI table.
[AltH] List of commands
[F1] Helpandfill
| PI | Patient Number | Institute | Last Name | First Name & MI |
| Ö 1 | NCI | Ö | Ö | |
Then press the [F10] key to select the OS table. In the Patient Number field, press the [F5] key and then press the [1] to establish the link. Checkmark (Ö) fields to be displayed and enter selection criteria displayed below; however, modify the date range in the On_Study field to reflect the previous month.
| OS | Patient Number | Protocol | On Study |
| 1 | Ö | Ö >=08/01/94,<=08/31/94 | |
| Treatment Group | Branch | Disease Type | Eligible? |
| Randomized? | Primary Site | Disease | BOCR |
| Protocol Type | Treatment Termination | Off Study | Off Study Reason |
Then press the [F10] key to select the FU table. In the Patient Number field, press the [F5] key and then press the [1] to establish the link. Checkmark (Ö) fields to be displayed and enter selection criteria displayed below.
| FU | Patient Number | Disease Type | Contact Date | AD Status | Death |
| 1 | Ö | Ö | |||
Press the [F2] key. The message, Processing query..., will appear on the screen while the system processes the request. Then, an Answer Table is produced. Sort the Answer Table, as described in Chapter 6, using Disease as the primary sort and Protocol as the secondary sort. This report is sorted two ways. The first sort is by the Protocol & Onstudy Date and the second report is sorted by the Disease Type. Both reports are titled based upon the branch, the sort performed and the month and year, e.g., PO PTS SORTED BY PROTOCOL/ONSTUDY 10/95. The reports are printed in the Landscape style and then faxed to Dorie Marshall in the Pediatric Branch.
This report is generated on the 15th of every month for the NCI-Navy Medical Oncology Branch. The report is generated through the "Reports" option in the Clinical Data Registry which is housed on the Gateway 2000 computer. Once you have entered this option, highlight Protocol and press the [Enter] key. Enter the date range for the report that needs to be processed. The system will automatically insert the "/" and the "to". The following information will appear on the screen:
| ACCRUALS MENU THE CLINICAL DATA REGISTRY | |
| PROTOCOL | Prepare and print the protocol accrual report. |
| DISEASE | Prepare and print the disease accrual report. |
| Report Period (Ex: 01/01/93 to 03/31/93): 01/01/70 to 10/31/95 |
Generating Protocol Accrual...
The message, Generating Protocol Accrual..., will flash on the screen while the system processes the request. When processing is completed, the following query screen will appear.
[F2]: Process query; [Esc]: Quit
[F3]: Up one line; [F4]: Down one line
\CDR\QUERIES\PROTACCRËÍÍPatient NumberÍÍËÍÍÍÍInstituteÍÍÍÍÍËÍÍÍÍÍLast NameÍÍÍÍ» ºÖ+ ºÖ+ ºÖ+ º º º º º º º º º ËÍÍFirst Name & MIÍÍÍËÍÍÍÍÍÍÍSexÍÍÍÍÍÍËÍÍÍÍÍRaceÍÍÍÍÍÍÍËÍÍÍÍÍProtocolÍÍÍÍÍÍÍ» ºÖ+ ºÖ+ ºÖ+ ºÖ+NOT..C....* º º º º º º º º º º º OSËÍÍÍÍÍOn_StudyÍÍÍÍÍÍÍËÍÍÍÍÍBranchÍÍÍÍÍÍÍÍÍËÍÍÍEligible?ÍÍÍËÍÍOff_StudyÍÍÍÍ» ºÖ+ ºÖ+ ºÖ+ º º º º º º º º º º º º
A Ö+ symbol is present in each field to indicate that the field has been selected and will appear in the report. The first three fields of the entire query will be displayed initially. To access remaining fields, use the [-Ø] cursor key. You have the option of selecting criteria for specific fields. To select only those patients who were treated at the NIH, type "NCI" in the Institute field. This will automatically include Navy Branch patients (NCIN). To exclude the protocols that contain an "*" at the end, use the cursor keys to move to the Protocol field, and type NOT ..C....* in the field. To specify the branch type "NV" in the Branch field. The report is automatically titled and printed. Once the report is finished, one copy is made and the original and the copy are couriered over to Sharon Thomas at the NCI-Navy.
Monthly reports are produced on the fifteenth of every month for the Navy Branch for a three month period using the CDR query utility. Monthly reports are provided to Sharon Thomas, Data Manager at the Navy Branch.
To begin this report you must first enter CDR and access the Utilities option, select Utilities from the Main Menu, as shown below.
Data_Entry Information Reports Utilities Configuration Exit Credits
Include adhoc queries and Mainframe backup.
ÉÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍ» º ±±±±±±±± MAIN MENU ±±±±±±±±±±±±±±±±±± THE CLINICAL DATA REGISTRY ±±±±±±±± º ÇÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÒÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄĶ º DATA_ENTRY º Edit patient related information and run offline edits.º ÌÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÎÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍ͹ º INFORMATION º OnLine singlepatient information retrieval. º ÌÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÎÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍ͹ º REPORTS º Prepare/Print various patient reports. º ÌÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÎÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍ͹ º UTILITIES º Include adhoc queries and Mainframe backup. º ÌÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÎÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍ͹ º CONFIGURATION º Include Password, and Lookup table modification. º ÌÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÎÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍ͹ º EXIT º Exit CDR and return to DOS. º ÈÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÊÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍͼ
Currently selected patient ³ None
You will get the following submenu. Each selection will be described in the following section.
Query Mainframe_Backup Branch_Connect
Use the powerful adhoc query system to ask your database any question
ÉÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍ» º±±±±±± UTILITIES MENU ±±±±±± THE CLINICAL DATA REGISTRY ±±±±±± º ÌÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍËÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍ͹ º QUERY º Use the Ad Hoc Query and report system. º ÇÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ×ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄĶ º MAINFRAME BACKUP º Create backup files to be uploaded to the º º º mainframe. º ÇÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ×ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄĶ º BRANCH CONNECT º Upload data sent periodically from º º º different branches. º ÈÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÊÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍͼ
Currently selected patient ³ None
To begin the first query, select the PI table. In the Patient Number field, press the [F6] key and then press the [F5] key and [1] to linkages among tables. Checkmark fields to be displayed and enter the selection criteria detailed below.
To begin the query, press the [F10] key, select the PI table. In the Patient Number field, press the [F6] key and then press the [F5] key and [1] to link the tables. Checkmark (ü) fields to be displayed by pressing F6 and enter the selection criteria detailed below.
[AltH] List of commands
[F1] Helpandfill
PIÍÍÍÍÍËÍÍPatient NumberÍÍËÍÍÍÍInstituteÍÍÍÍÍËÍÍÍÍLast NameÍÍÍÍÍËÍFirst NameÍÍÍË ºÖ 1 º NCI OR NCIN ºÖ ºÖ º º º º º º º º º º º ËÍÍÍÍSexÍÍÍÍËÍÍÍÍRaceÍÍÍÍËÍÍÍÍDate of BirthÍÍÍÍË ºÖ ºÖ ºÖ º º º º º º º º º
Then press the [F10] key to select the OS table. In the Patient Number field, press the [F5] key and then press the [1] to establish the link. Checkmark (Ö) the fields to be displayed and enter selection criteria displayed below; however, modify the date range in the On_Study field to reflect the previous month (for the monthly report).
In the example below, a monthly report is specified.
OSÍÍÍÍÍËÍÍPatient NumberÍÍËÍÍÍÍÍÍÍÍÍÍÍÍProtocolÍÍÍÍÍÍËÍÍÍÍOn_StudyÍÍÍÍÍÍÍÍÍÍÍÍÍÍË º 1 ºÖNOT ..C....* º Ö >=10/01/95,<=10/31/95 º º º º º º º º º ËÍTreatment GroupÍÍËÍÍÍÍÍÍBranchÍÍÍÍÍÍËÍÍÍDisease TypeÍÍÍËÍÍÍÍEligible?ÍÍÍÍÍË º º NV ºÖ ºÖ º º º º º º º º º º º ËÍÍÍRandomized?ÍÍÍÍËÍÍÍÍÍDiseaseÍÍÍÍÍÍËÍÍÍÍOff_StudyÍÍÍÍÍËÍOff_Study ReasonÍË º º ºÖ º Ö º º º º º º º º º º º
ËÍÍÍCompleted ByÍÍÍËÍÍÍDate CompletedÍÍÍË º º º º º º º º º
Then press the [F10] key to select the FU table. In the Patient Number field, press the [F5] key and then press the [1] to establish the link. Checkmark (Ö) the fields to be displayed and enter selection criteria displayed below.
FUËÍÍPatient NumberÍÍËÍÍDisease TypeÍÍÍËÍÍContact DateÍÍËÍÍAD StatusÍÍËÍÍDeathÍÍ» º 1 º º ºÖ º º º º º º º º º º º º º º
Press the [F2] key. The message, Processing query..., will appear on the screen while the system processes the request. Once the request is finished processing, the data will be displayed on the screen. At this point the report needs to be sorted by the onstudy date. To sort the data, press F7, and S for sort. When the sort criteria appears type 1 next to the protocol, type 2 next to the last name and type 3 next to the first name, then press F2 to process the sort.
Now the report is ready to be printed. To print the report, again press F7 and P to print. on the screen will appear a text box for the title. This report is titled Navy Adhoc Query Sorted By Protocol/Name, then press L for Landscape and the printing will begin. Once the report is printed, send it to Sharon Thomas, Data Manager for the Naval Oncology Branch.
To access reporting options, use the cursor keys to highlight Reports on the Main Menu. Then press the [×ÄÙEnter] key. The Reports option provides access to the standard reports developed to meet most of the reporting requirements.
Data_Entry Information Reports Utilities Configuration Exit Credits
Prepare/Print various patient reports
ÉÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍ» º ±±±±±±±± MAIN MENU ±±±±±±±±±±±±±±±±±± THE CLINICAL DATA REGISTRY ±±±±±±±± º ÇÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÒÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄĶ º DATA_ENTRY º Edit patient related information and run offline edits.º ÌÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÎÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍ͹ º INFORMATION º OnLine singlepatient information retrieval. º ÌÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÎÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍ͹ º REPORTS º Prepare/Print various patient reports. º ÌÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÎÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍ͹ º UTILITIES º Include adhoc queries and Mainframe backup. º ÌÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÎÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍ͹ º CONFIGURATION º Include Password, and Lookup table modification. º ÌÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÎÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍ͹ º EXIT º Exit CDR and return to DOS. º ÈÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÊÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍͼ
Currently selected patient ³ None
The Report Menu, shown below, is displayed. The five types of reports are discussed at the beginning of each of the following sections.
IRB Summary
The IRB Summary Report is produced monthly and provides a summary of sex and race statistics for specific protocols to be reviewed by the Institutional Review Board. The protocols included in this report are determined by the Institutional Review Board (IRB), and a list of selected protocols is provided to The Orkand Corporation by Jane Cassidy (Phone 301-496-4251). To access this option, select Reports from the Main Menu to display the Report Menu. Follow the procedures listed below to generate the IRB Summary Report.
1. To select the IRB Report, use the cursor to highlight the IRB option from the Report Menu and press the [×ÄÙEnter] key to select this option.
This appendix contains selection criteria used to produce the following four quarterly reports: Quarterly Protocol Accrual Summary, Protocol Accrual, AIDS, AMGEM, and Maryland State Registry.
This report is produced each quarter and is due one and a half months after the end of the quarter. To run this report, select the Summaries option from the Report Menu and then select the Protocol option from the Summaries Menu. The report is run twice -- for the most recently completed quarter and for the period beginning January 1, 1970 and ending on
the last day of the most recently completed quarter. Enter the appropriate date ranges in the box requesting the report period. This date range will appear automatically in the On_Study field.
The selections for the period of the quarter are displayed below.
Enter additional query specifications in fields below.
Press F1 for help or F2 when done (selections in a field separated by "or").
ËÍÍÍÍÍÍÍÍÍÍÍÍProtocolÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍËÍÍÍÍÍÍÍÍÍÍOn_StudyÍÍÍÍÍÍÍÍÍÍË º NOT ..C....* º >=04/01/94,<=06/30/94 º º º º º º º ËÍÍÍÍÍÍBranchÍÍÍÍÍÍËÍÍÍDiseaseTypeÍÍÍËÍÍÍÍEligible?ÍÍÍÍÍËÍÍÍÍÍDiseaseÍÍÍÍÍ» º º º º º º º º º º º º º º º ËÍÍProtocol TypeÍÍÍËÍÍÍÍOff_StudyÍÍÍÍËÍÍOff_Study ReasonÍÍËÍÍÍInstituteÍÍÍÍ» º º º º NCI º º º º º º º º º º º
The selections for the period to date are displayed below.
Enter additional query specifications in fields below.
Press F1 for help or F2 when done (selections in a field separated by "or").
ËÍÍÍÍÍÍÍÍÍÍÍÍProtocolÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍËÍÍÍÍÍÍÍÍÍÍOn_StudyÍÍÍÍÍÍÍÍÍÍË º NOT ..C....*, NOT ..CM..., º >=01/01/70,<=06/30/94 º º NOT ..C9..., NOT ..C..SCR º º º º º ËÍÍÍÍÍÍBranchÍÍÍÍÍÍËÍÍÍDiseaseTypeÍÍÍËÍÍÍÍEligible?ÍÍÍÍÍËÍÍÍÍÍDiseaseÍÍÍÍÍ» º º º º º º º º º º º º º º º ËÍÍProtocol TypeÍÍÍËÍÍÍÍOff_StudyÍÍÍÍËÍÍOff_Study ReasonÍÍËÍÍÍInstituteÍÍÍÍ» º º º º NCI º º º º º º º º º º º
**NOTE: In the "Protocol" field, enter the "NOT" selections all on one contiguous line. Only two were entered per line in the above example for space considerations.
This report is produced quarterly and is due one and a half months after the end of the quarter. Unlike other quarterly reports, it is divided into sections for each branch, and the relevant section then is distributed to a representative from each branch. The Protocol Accrual Report provides a listing, by branch, of patients who were being treated or followed on protocols during the previous quarter. The report is used for quality assurance (QA) purposes to identify those patients included in the Summary Report totals. Branches review the report to ensure that the data in CDR is consistent with branch records and report differences to The Orkand Corporation.
To run this report, select the Accruals option from the Report Menu and then select the Protocol option from the Accruals Menu. The report is run for the most recently completed quarter. Enter the appropriate date ranges in the requesting the report period. The date range will appear automatically in the On_Study field.
The selections for the of the quarter are displayed below.
Enter additional query specifications in fields below.
Press F1 for help or F2 when done (selections in a field separated by "or").
ËÍÍÍÍÍÍÍÍÍÍÍÍProtocolÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍËÍÍÍÍÍÍÍÍÍÍOn_StudyÍÍÍÍÍÍÍÍÍÍË º º >=04/01/94,<=06/30/94 º º º º º º º ËÍÍÍÍÍÍBranchÍÍÍÍÍÍËÍÍÍDiseaseTypeÍÍÍËÍÍÍÍEligible?ÍÍÍÍÍËÍÍÍÍÍDiseaseÍÍÍÍÍ» º º º º º º º º º º º º º º º ËÍÍProtocol TypeÍÍÍËÍÍÍÍOff_StudyÍÍÍÍËÍÍOff_Study ReasonÍÍËÍÍÍInstituteÍÍÍÍ» º º º º NCI º º º º º º º º º º º
This report is produced each quarter and is due one month after the end of the quarter. To run this report, 1970 and ending on the last day of the most recently completed quarter. Enter the appropriate date ranges in the box requesting the report period. This date range will appear automatically in the On_Study field.
The AMGEN report includes GCSF protocols only. A list, which is provided by Jane Cassidy (496-4251), identifies the specific protocols that should be included. Type each protocol number, separated by "OR", from the list in the Protocol field.select the Summaries option from the Report Menu and then select the Protocol option from the Summaries Menu. The report is run twice -- for the most recently completed quarter and for the period beginning January 1,
The selections for the quarter are displayed below.
Enter additional query specifications in fields below.
Press F1 for help or F2 when done (selections in a field separated by "or").
ËÍÍÍÍÍÍÍÍÍÍÍÍProtocolÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍËÍÍÍÍÍÍÍÍÍÍOn_StudyÍÍÍÍÍÍÍÍÍÍË º 93C0108 OR 88C0225 OR 90C0191 OR... º >=04/01/94,<=06/30/94 º º º º º º º ËÍÍÍÍÍÍBranchÍÍÍÍÍÍËÍÍÍDiseaseTypeÍÍÍËÍÍÍÍEligible?ÍÍÍÍÍËÍÍÍÍÍDiseaseÍÍÍÍÍ» º º º º º º º º º º º º º º º ËÍÍProtocol TypeÍÍÍËÍÍÍÍOff_StudyÍÍÍÍËÍÍOff_Study ReasonÍÍËÍÍÍInstituteÍÍÍÍ» º º º º NCI º º º º º º º º º º º
The selections for the period to date are displayed below.
Enter additional query specifications in fields below.
Press F1 for help or F2 when done (selections in a field separated by "or").
ËÍÍÍÍÍÍÍÍÍÍÍÍProtocolÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍÍËÍÍÍÍÍÍÍÍÍÍOn_StudyÍÍÍÍÍÍÍÍÍÍË º 93C0108 OR 88C0225 OR 90C0191 OR... º >=01/01/70,<=06/30/94 º º º º º º º ËÍÍÍÍÍÍBranchÍÍÍÍÍÍËÍÍÍDiseaseTypeÍÍÍËÍÍÍÍEligible?ÍÍÍÍÍËÍÍÍÍÍDiseaseÍÍÍÍÍ» º º º º º º º º º º º º º º º ËÍÍProtocol TypeÍÍÍËÍÍÍÍOff_StudyÍÍÍÍËÍÍOff_Study ReasonÍÍËÍÍÍInstituteÍÍÍÍ» º º º º NCI º º º º º º º º º º º
Upon completing all of the error checking, you must follow the following steps to ensure the proper information is downloaded from CDR to the mainframe so David Blessely of DCRT (computer center) can retrieve the file. Follow this procedure:
Before you begin the transfer program, first get into the WYLBUR application and delete the existing "INDRA.txt" file. Follow this procedure to enter and delete files from Wylbur:
1. At the C:\ prompt on the Trinitron Dell type WIN
2. In the windows double click on the Network
3. Double click on the WYLBUR icon
4. At the HELP: type Logon
5. Type JAG at the initials prompt, type NCPC at the Account prompt and type RAND at the password prompt
6. At ready type WYLBUR
7. Type sh dsns like &ncpcjag.indra.txt [ENTER]
8. Then at the next ? type scratch &ncpcjag.indra.txt [ENTER]
9. At the ? type logoff clear
10. Click on "FILE" from the menu bar and click on "close". It will ask you if you want to exit the windows session, click on ok.
After you have deleted the existing .txt file you are ready to begin the procedure for the Maryland State Registry.
1. Get the C:\ prompt on the Gateway 2000 computer and type: PARADOX
2. Type "A" for "ASK", hit ENTER
3. Type "PI", hit ENTER
4. Type "PA", hit ENTER
5. At the Query Screen, select PATIENT #, LAST NAME and FIRST NAME by using F6. In addition, for the PATIENT # field ONLY, press F5 then hit "1"
6. For the INSTITUTION field, type in "NCI"
7. Press F10, type "A", then select "OS", type "OA" and hit ENTER
8. For the PATIENT # field, press F5 then 1. For the PROTOCOL and ONSTUDY DATE, press F6. Also, in the ONSTUDY DATE field, type in the following: >=01/01/94, <=03/31/94 (where 01/01/94 is the first date in the quarter you are dealing with and 03/31/94 is the end of the quarter)
9. Press F6 also in the following fields: BRANCH, PRIMARY SITE, and DISEASE. For the ELIGIBLE? field, type: "Y OR BLANK" and press F6
10. Press F10, type "A", select "FU", then type "FA" and hit ENTER
11. For the PATIENT # field, press F5 then 1. For the CONTACT DATE, and ALIVE/DEAD STATUS, press F6.
12. Press F2 to process the list.
13. Press F10, choose TOOLS, then RENAME, then when prompted, TABLE=ANSWER
14. NEW NAME = INDRA (always rename the file "INDRA")
15. Replace the file.
16. Exit PARADOX
17. At the C:\ prompt, type: PARADOX \CDR\SCRIPTS\INDRA, then hit ENTER.
18. At the C:\ prompt, type: WIN, then hit ENTER
19. Double click on the "FTP" icon on the mainframe
20. Type: JAG, at user command, then hit ENTER.
21. Type: RAND, at the password command, then hit ENTER (THIS PASSWORD WILL PERIODICALLY CHANGE)
22. Type: NCPC, at the account command, then hit ENTER
23. Type: SEND C:\CDR\DATA\INDRA.TXT INDRA.TXT and then hit ENTER
24. Type: BYE, hit ENTER
After following this procedure, call David Blessely at 301-496-3401 and tell him that the quarterly data has been placed on the mainframe for the Maryland State Registry. Remind him that our ID#'s are 9 digits (they have two zeros preceding the normal 7 other digits) and that the file is saved under: JAG NCPC
Building 10.
ROB data is also placed on the Protocol Office server.
Use a separate PC formatted disk when downloading this data from the Macintosh upstairs and follow the instructions in the CDR Users Manual.
Surgery Branch data is placed on the NIH mainframe.
This data can be accessed by the CDR computer using a PC formatted disk.
Follow instructions in the CDR Users Manual.
Patient data that is not imported through the branch connection procedure i.e., faxed registrations from Navy, Pediatric, Surgery (non-immunotherapy), Metabolism, and Dermatology branches is entered manually into the system. Patient data is verified in MIS for demographic information like patient ID, name, sex, race, and DOB. The after entering the forms they are filed in the respective binders.
The batch edit program is run on the data on a monthly basis for editing and quality assurance purposes. On a regular basis adhoc queries are run to check for duplicate records, missing sex, race or DOB information, etc. Reports are run on monthly basis and sent to the branches to control the quality of the data. As the data is imported from outside goes through an edit check, thus allowing only good data to be imported.
All new CDR data is also verified during the production of the weekly reports: All Patients Registered to DCS and All New Patients Registered to DCS. While producing these reports, data for all patients which are either new to NCI or registered onto a new protocol is verified. Correct name, patient number, protocol number, protocol type, DCS Branch, and on study date is checked against the Clinical Center's Medical Information System as well as against the original patient registration checklist.
Monthly protocol accrual status reports are sent to each DCS Branch for their review. The Branch staff (Principal Investigators or Research Nurses) verify that the patients listed as on study contain correct information for: Patient Name, Patient Number, Sex, Race, On Study Date, Off Study Date, Protocol Type, Eligibility, and Institute.
The Clinical Data Registry is maintained and used on an IBM compatible personal computer in the central office. In order to prevent permanent loss of data, data will be backed-up monthly and stored in the Data Vault.
Back-up tapes are created using an Iomega Ditto Easy external tape back-up. To create a system back-up, simply click the One-Step Back-up Icon at the bottom of the screen. The program now states that it can now create a full back-up. Click "OK". The tape rewinds and begins creating the data back-up. The system will allow 3.2 megabytes to be stored on each tape. After the tape is complete, eject it from the tape-drive, label the tape with content and date, and store in the Data Vault.