CDE Detailed Report
Subdomain Name: 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 | 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 / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 docume | 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 grou | 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 | |||||||||
| 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 stud | 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 |
