CDE Detailed Report

Disease: General (For all diseases)
Sub-Domain: Participant/Subject Identification, Eligibility, and Enrollment
CRF: Informed Consent and Enrollment

Displaying 1 - 6 of 6
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C02209 Informed consent obtained indicator InfConsntObtInd Indicator of whether informed consent was obtained for the participant/subject to participate in the clinical research study. Indicator of whether informed consent was obtained for the participant/subject to participate in the clinical research study Was informed consent obtained? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. If YES, record date informed consent was obtained.

No references available Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Informed Consent and Enrollment Participant/Subject Identification, Eligibility, and Enrollment Protocol Experience

Single Pre-Defined Value Selected

2186028
C02210 Enrolled in study indicator EnrldStdyInd Indicator of whether the participant/subject was enrolled into the clinical research study. Indicator of whether the participant/subject was enrolled into the clinical research study. Was the participant/subject enrolled into the study? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. If YES, record the date enrolled.

No references available Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Informed Consent and Enrollment Participant/Subject Identification, Eligibility, and Enrollment Protocol Experience

Single Pre-Defined Value Selected

3152168
C02211 Enrolled in study date and time EnrldStdyDateTime Date (and time, if applicable and known) the participant/subject is enrolled into the study Date (and time, if applicable and known) the participant/subject is enrolled into the study Date Enrolled Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date (and time) should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database.

No references available Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Informed Consent and Enrollment Participant/Subject Identification, Eligibility, and Enrollment Protocol Experience

Free-Form Entry

2434998,2746541
C02212 Informed consent obtained date and time InformConsntObtnDateTime Date (and time, if applicable and known) on which the participant/subject (or the legal representative on behalf of the participant/subject) agrees to participate in a protocol, treatment, or other activity by signing an informed consent document. Date (and time, if applicable and known) on which the participant/subject (or the legal representative on behalf of the participant/subject) agrees to participate in a protocol, treatment, or other activity by signing an informed consent document. Date of Consent Date or Date & Time

Record the date(and time) the informed consent form is signed. The date/time should be recorded to the level of granularity known(e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Informed Consent and Enrollment Participant/Subject Identification, Eligibility, and Enrollment Protocol Experience

Free-Form Entry

2435038,656
C02213 Randomized indicator RandomizedInd Indicator of whether the participant/subject was randomly assigned (i.e., by chance not choice) to an intervention/treatment group or control group. Indicator of whether the participant/subject was randomly assigned (i.e., by chance not choice) to an intervention/treatment group or control group Was the participant/subject randomized? Yes;No;Not applicable Yes;No;Not applicable Alphanumeric

Choose one. If YES, record the date randomized. This CDE should only be on the CRF if the study is a randomized clinical trial. Otherwise, it can be removed.

No references available Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Informed Consent and Enrollment Participant/Subject Identification, Eligibility, and Enrollment Protocol Experience

Single Pre-Defined Value Selected

2183079
C02214 Randomized date and time RandomizedDateTime Date (and time, if applicable and known) the participant/subject is randomly assigned (i.e., by chance not choice) to an intervention/treatment group or control group. Date (and time, if applicable and known) the participant/subject is randomly assigned (i.e., by chance not choice) to an intervention/treatment group or control group. Date randomized Date or Date & Time

Record the date(and time) the participant/subject is randomized to a treatment or control group. The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database. This CDE should only be included on the CRF if the study is a randomized clinical trial. Otherwise, it can be removed.

No references available Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Informed Consent and Enrollment Participant/Subject Identification, Eligibility, and Enrollment Protocol Experience

Free-Form Entry

2182072,2186028
CSV