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This is an example CRF used to collect the protocol milestone, and informed consent. 

Example CRF:  Protocol milestones (e.g., informed consent) 

DSCAT DSCAT="PROTOCOL MILESTONE" where DSDECOD and DSTERM="INFORMED CONSENT OBTAINED"
Hidden/pre-populated
PROTOCOL MILESTONE
<DSCAT codelist>
Record the date of informed consent as defined in the protocol and/or CRF completion instructions using this format (DD-MON-YYYY).
DSSTDAT DSSTDTC
_ _ / _ _ _ / _ _ _ _
Record the time (as complete as possible) of informed consent as defined in the protocol and/or CRF completion instructions.
DSSTTIM DSSTDTC
_ _ : _ _ : _ _
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target ValueSDTMIG Target MappingControlled Terminology Code List NameCRF Implementation NotesPermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
DSCAT1What was the category of the disposition?Disposition CategoryIf collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.TextDSCATDSCAT="PROTOCOL MILESTONE" where DSDECOD and DSTERM="INFORMED CONSENT OBTAINED"(DSCAT)Refer to the SDTMIG for guidelines for assigning DSCAT, DSTERM, and DSDECOD for events considered protocol milestones.
PROTOCOL MILESTONEprompt
Yes
DSSTDAT2What was the informed consent date?Informed Consent DateRecord the date of informed consent as defined in the protocol and/or CRF completion instructions using this format (DD-MON-YYYY).DateDSSTDTC




qtext

DSSTTIM3What was the informed consent time?Informed Consent TimeRecord the time (as complete as possible) of informed consent as defined in the protocol and/or CRF completion instructions.TimeDSSTDTC




qtext

This is an example CRF used to collect Disposition Events. In this study, subjects were randomized to a trial, which contain three epochs. A screening epoch, a product exposure epoch,, where subjects were required to use the tobacco product as described in the protocol, and a follow-up epoch. The Disposition Event CRF was collected at the end of each epoch of the trial. The sponsor may select the the Completion/Reason for Non-Completion terms from Controlled Terminology.    

Example CRF :Study Participation Disposition Event

DSCAT
Hidden/pre-populated
DISPOSITION EVENT
<DSCAT codelist>
Select the trial epoch for which disposition is being recorded.Epoch
EPOCH
<EPOCH codelist>
Record the date that the subject completed the study or trial period using this format (DD-MON-YYYY). If the subject did not complete the study or trial period, record the date that the subject discontinued.
DSSTDAT DSSTDTC
_ _ / _ _ _ / _ _ _ _
Record the time (as complete as possible) that the subject completed the study or trial period as defined in the protocol. If the subject did not complete the study or trial period, record the time (as complete as possible).
DSSTTIM DSSTDTC
_ _ : _ _ : _ _
Document the subject's status for the study or trial period. If the subject discontinued prematurely, record the primary reason for discontinuation.What was the subject's status?
DSDECOD
<NCOMPLT codelist>
If Adverse Event, Death, Protocol Deviation or Other is selected from the Status list, provide the verbatim reason.
DSTERM
_________________
Record if the subject will be continuing to the next trial period of this study.Will the subject continue?
DSCONT SUPPDS.QVAL when SUPPDS.QNAM= "DSCONT" and SUPPDS.QLABEL="Subject Continue".
<NY codelist>
Record the planned subsequent trial epoch in which the subject intends to participate.What is the next epoch the subject will continue to enter?
DSNEXT Not Submitted
<EPOCH codelist>
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
DSCAT1What was the category of the disposition?Disposition CategoryIf collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.TextDSCAT
(DSCAT)
DISPOSITION EVENTprompt
Yes
EPOCH2What is the trial epoch for this disposition event?EpochSelect the trial epoch for which disposition is being recorded.TextEPOCH
(EPOCH)SCREENING; TREATMENT;  FOLLOW-UP;
promptradio
DSSTDAT3What was the completion/discontinuation date?

Completion/Discontinuation Date

Record the date that the subject completed the study or trial period using this format (DD-MON-YYYY). If the subject did not complete the study or trial period, record the date that the subject discontinued.DateDSSTDTC






DSSTTIM4What was the completion/discontinuation time?Completion/Discontinuation TimeRecord the time (as complete as possible) that the subject completed the study or trial period as defined in the protocol. If the subject did not complete the study or trial period, record the time (as complete as possible).TimeDSSTDTC






DSDECOD5What was the subject's status?StatusDocument the subject's status for the study or trial period. If the subject discontinued prematurely, record the primary reason for discontinuation.TextDSDECOD
(NCOMPLT)COMPLETED; ADVERSE EVENT; DEATH; LACK OF EFFICACY; LOST TO FOLLOW-UP; NON-COMPLIANCE WITH STUDY DRUG; PHYSICIAN DECISION; PREGNANCY;  PROTOCOL DEVIATION; SITE TERMINATED BY SPONSOR; STUDY TERMINATED BY SPONSOR;  WITHDRAWAL BY SUBJECT; OTHER

radio
DSTERM6If other, specifySpecifyIf Adverse Event, Death, Protocol Deviation or Other is selected from the Status list, provide the verbatim reason.TextDSTERM



prompt

DSCONT7Will the subject continue?Continue

Record if the subject will be continuing to the next trial period of this study.

TextSUPPDS.QVALSUPPDS.QVAL when SUPPDS.QNAM= "DSCONT" and SUPPDS.QLABEL="Subject Continue".(NY)No; Yes

radio
DSNEXT8What is the next epoch the subject will continue to enter?Next epochRecord the planned subsequent trial epoch in which the subject intends to participate.TextN/A
(EPOCH)TREATMENT;  FOLLOW-UP;



This is an example of an SDTM dataset used to represent the data collected on the above example CRFs. 

Rows 1, 2, 6, 8, 9, 12, 13, 17, 18:Show records for protocol milestones. DSTERM and DSDECOD are populated with the same value, the name of the milestone. Note that for randomization events, EPOCH = "SCREENING", because randomization occurred before the start of product exposure, during the screening epoch.
Rows 3-5:Show 3 records for a subject who completed 3 stages of the study ("SCREENING", "PRODUCT EXPOSURE", "FOLLOW-UP").
Row 7:Shows disposition of a subject who was a screen failure. The Disposition CRF showed that the subject discontinued for a " PROTOCOL DEVIATION ". The specify reason the subject was a screen failure was then collected using DSTERM. Because the subject did not complete the screening epoch, DSDECOD is not “COMPLETED” but another appropriate controlled term, "PROTOCOL DEVIATION ". The date of discontinuation is in DSSTDTC. The protocol deviation event itself would be represented in the DV dataset.
Rows 10-11:Show disposition of a subject who completed the screening stage but did not complete the protocol exposure epoch. For completed epochs, both DSTERM and DSDECOD are "COMPLETED". For epochs that were not completed, the verbatim reason for non-completion of the product exposure epoch is in DSTERM, while the value from controlled terminology is in DSDECOD.
Rows 14-16:Show disposition of a subject who completed prouduct exposure epoch, but did not complete follow-up. Note that for final disposition event, the date of collection of the event information, DSDTC, was different from the date of the disposition event (the subject's death), DSSTDTC.
Rows 19-21:Show disposition of a subject who discontinued the product exposure epoch due to an adverse event, but who went on to complete the follow-up epoch of the trial.

ds.xpt

ds.xpt

RowSTUDYIDDOMAINUSUBJIDDSSEQDSTERMDSDECODDSCATDSSCATEPOCHDSDTCDSSTDTC
1ABC123DS1231011INFORMED CONSENT OBTAINEDINFORMED CONSENT OBTAINEDPROTOCOL MILESTONE
SCREENING2003-09-212003-09-21
2ABC123DS1231012RANDOMIZEDRANDOMIZEDPROTOCOL MILESTONE
SCREENING2003-09-302003-09-30
3ABC123DS1231013COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONSCREENING2003-09-302003-09-29
4ABC123DS1231014COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONPRODUCT EXPOSURE2003-10-312003-10-31
5ABC123DS1231015COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONFOLLOW-UP2003-11-152003-11-15
6ABC123DS1231021INFORMED CONSENT OBTAINEDINFORMED CONSENT OBTAINEDPROTOCOL MILESTONE
SCREENING2003-11-212003-11-21
7ABC123DS1231022SUBJECT DENIED MRI PROCEDUREPROTOCOL VIOLATIONDISPOSITION EVENTSTUDY PARTICIPATIONSCREENING2003-11-222003-11-20
8ABC123DS1231031INFORMED CONSENT OBTAINEDINFORMED CONSENT OBTAINEDPROTOCOL MILESTONE
SCREENING2003-09-152003-09-15
9ABC123DS1231032RANDOMIZEDRANDOMIZEDPROTOCOL MILESTONE
SCREENING2003-09-302003-09-30
10ABC123DS1231033COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONSCREENING2003-09-302003-09-22
11ABC123DS1231034SUBJECT MOVEDLOST TO FOLLOW-UPDISPOSITION EVENTSTUDY PARTICIPATIONPRODUCT EXPOSURE2003-10-312003-10-31
12ABC123DS1231041INFORMED CONSENT OBTAINEDINFORMED CONSENT OBTAINEDPROTOCOL MILESTONE
SCREENING2003-09-152003-09-15
13ABC123DS1231043RANDOMIZEDRANDOMIZEDPROTOCOL MILESTONE
SCREENING2003-09-302003-09-30
14ABC123DS1231042COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONSCREENING2003-09-302003-09-22
15ABC123DS1231044COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONPRODUCT EXPOSURE2003-10-152003-10-15
16ABC123DS1231045AUTOMOBILE ACCIDENTDEATHDISPOSITION EVENTSTUDY PARTICIPATIONFOLLOW-UP2003-10-312003-10-29
17ABC123DS1231051INFORMED CONSENT OBTAINEDINFORMED CONSENT OBTAINEDPROTOCOL MILESTONE
SCREENING2003-09-282003-09-28
18ABC123DS1231052RANDOMIZEDRANDOMIZEDPROTOCOL MILESTONE
SCREENING2003-10-022003-10-02
19ABC123DS1231053COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONSCREENING2003-10-022003-10-02
20ABC123DS1231054ANEMIAADVERSE EVENTDISPOSITION EVENTSTUDY PARTICIPATIONPRODUCT EXPOSURE2003-10-172003-10-17
21ABC123DS1231055COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONFOLLOW-UP2003-11-022003-11-02
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