CDE Detailed Report
Disease: General (For all diseases)
Subdomain Name: Participant/Subject Identification, Eligibility, and Enrollment
CRF: Screening Log
Displaying 1 - 17 of 17
Subdomain Name: Participant/Subject Identification, Eligibility, and Enrollment
CRF: Screening Log
Displaying 1 - 17 of 17
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Enrolled | 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 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience |
Single Pre-Defined Value Selected |
3152168 | |||||||
| C18751 | Sex participant or subject genotype other text | SexSubjectGenotypOTH | The free-text field related to 'Sex participant or subject genotype type' specifying other text. The difference between male and female, based upon the interactions between genes and between the genotype and the environment. Genotype is identified based on the individual's reproductive organs and functions assigned by chromosomal complement | The free-text field related to 'Sex participant or subject genotype type' specifying other text. Sex chromosomes of the participant/subject based upon genotyping | Other, specify | Alphanumeric |
No instructions available |
No references available | Adult;Pediatric | Supplemental | 1.00 | 2014-05-27 13:34:46.0 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience | 4000 |
Free-Form Entry |
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| 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 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience |
Free-Form Entry |
2434998,2746541 | |||||||||
| C19069 | Screening visit eligibility other text | ScreenVisitEligibilityOTH | The free-text field related to 'Screening visit eligibility status' specifying other text. The status determined from screening criteria that indicates whether a participant/subject may be eligible for a study | The free-text field related to 'Screening visit eligibility status' specifying other text. The status determined from screening criteria that indicates whether a participant/subject may be eligible for a stud | Other, specify | Alphanumeric | No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 16:35:19.49 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience | 4000 |
Free-Form Entry |
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| C02216 | Exclusion criterion not met number | ExclusionCriterionNotMetNum | Exclusion criterion number(s) the participant/subject did not meet | Exclusion criterion number(s) the participant/subject did not meet | Exclusion Number | Alphanumeric |
Enter the number(s) for the exclusion criterion/criteria the participant/subject did not meet. Multiple numbers should be separated by a comma. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 14:26:06.9 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience | 255 |
Free-Form Entry |
3151311 | ||||||||
| C19070 | Screening visit ineligibility primary other text | ScreenVisitIneligPrimryOTH | The free-text field related to 'Screening visit ineligibility primary reason' specifying other text. The primary reason identified during a screening visit which makes the potential participant/subject not eligible for a study | The free-text field related to 'Screening visit ineligibility primary reason' specifying other text. The primary reason identified during a screening visit which makes the potential participant/subject not eligible for a stud | Other, specify | Alphanumeric |
If not eligible, choose one. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 16:35:19.49 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience | 4000 |
Free-Form Entry |
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| C02217 | Inclusion criterion not met number | InclusionCriterionNotMetNum | Inclusion criterion number(s) the participant/subject did not meet | Inclusion criterion number(s) the participant/subject did not meet | Inclusion Number | Alphanumeric |
Enter the number(s) for the inclusion criterion/criteria the participant/subject did not meet. Multiple numbers should be separated by a comma. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 14:26:06.9 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience | 255 |
Free-Form Entry |
3151307 | ||||||||
| C19071 | Screening visit not enrolled primary other text | ScreenVisitNotEnrldPrimryOTH | The free-text field related to 'Screening visit not enrolled primary reason' specifying other text. The primary reason to indicate why the potential participant/subject is not enrolled in a study during a screening visit | The free-text field related to 'Screening visit not enrolled primary reason' specifying other text. The primary reason to indicate why the potential participant/subject is not enrolled in a study during a screening visi | Other, specify | Alphanumeric |
If not enrolled, choose one. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 16:35:19.49 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience | 4000 |
Free-Form Entry |
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| C17396 | Sex genotype type | SexGenotypTyp | The difference between male and female, based upon the interactions between genes and between the genotype and the environment. Genotype is identified based on the individual's reproductive organs and functions assigned by chromosomal complement | Sex chromosomes of the participant/subject based upon genotyping | Sex | XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Unspecified | XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Undifferentiated/Indeterminant/Intersex | Alphanumeric |
No instructions available |
No references available | Adult;Pediatric | Supplemental | 3.10 | 2018-07-26 00:00:00.0 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience |
Single Pre-Defined Value Selected |
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| C17399 | Global unique identifier number | GlobalUniqueIdNum | Number representing the Global Unique ID (GUID) which uniquely identifies a participant | Number representing the Global Unique ID (GUID) which uniquely identifies a participant | Screening ID | Alphanumeric | Johnson, S.B., Whitney, G., McAuliffe, M., Wang, H., McCreedy, E., Rozenblit, L., and Evans, C.C. (2010). Using Global Unique identifiers to link autism collections. J. Am. Med. Inform. Assoc., in press. Published online July 17, 2010. 10.1136/jamia.2009.002063. | Adult;Pediatric | Supplemental | 3.10 | 2024-02-29 15:54:17.0 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience | 255 |
Free-Form Entry |
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| C18492 | Screening visit date and time | ScreenVisitDateTime | Date (and time, if applicable and known) the participant/subject was interviewed and screened for potential enrollment into the study | Subject screened date and time | Screening Date | 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 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience |
Free-Form Entry |
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| C18493 | Screening visit eligibility status | ScreenVisitEligibilityStatus | The status determined from screening criteria that indicates whether a participant/subject may be eligible for a study | Screening visit eligibility status | Eligibility | Eligible;Eligible but declined;Not eligible;Other, specify | Eligible;Eligible but declined;Not eligible;Other, specify | Alphanumeric | No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 16:35:19.49 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience |
Single Pre-Defined Value Selected |
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| C18494 | Screening visit ineligibility primary reason | ScreenVisitIneligPrimryRsn | The primary reason identified during a screening visit which makes the potential participant/subject not eligible for a study | The primary reason identified during a screening visit which makes the potential participant/subject not eligible for a stud | Primary Reason | Inclusion;Exclusion;Other, specify | Inclusion;Exclusion;Other, specify | Alphanumeric |
If not eligible, choose one. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 16:35:19.49 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience |
Single Pre-Defined Value Selected |
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| C00007 | Birth date | BirthDate | Date (and time, if applicable and known) the participant was born | Date (and time, if applicable and known) the participant was born | Date of birth | 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/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.). Recording date of birth will give the most detailed information required for calculation of age and is recommended as first choice. However, in some studies recording date of birth may elicit discussions on a potential violation of privacy legislation and specifically HIPAA regulations. In these cases, the calculated age should be recorded. |
ISO 8601 -https://www.iso.org/home.html<br />Management and prognosis of severe traumatic brain injury: Age. J Neurotrauma. 2000;17:573-581.; Mushkudiani NA, Engel DC, Steyerberg EW, et al. Prognostic value of demographic characteristics in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):259-69. Pediatric-specific reference(s): Anderson V, Catroppa C, Morse S, Haritou F, Rosenfeld J (2005) Functional plasticity or vulnerability after early brain injury. Pediatrics 116:1374-1382 | Adult;Pediatric | Core | 3.1 | 10/16/2024 8:51:14 AM | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience |
Free-Form Entry |
793 | |||||||||
| C18495 | Protocol ID number | ProtIDNum | The designated number used to identify the protocol or study to which participants/subjects will be enrolled | The designated number used to identify the protocol or study to which participants/subjects will be enrolle | Study ID | Alphanumeric | No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 16:35:19.49 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience | 255 |
Free-Form Entry |
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| 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 | 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 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience |
Single Pre-Defined Value Selected |
2186028 | |||||||
| C18496 | Screening visit not enrolled primary reason | ScreenVisitNotEnrldPrimryRsn | The primary reason to indicate why the potential participant/subject is not enrolled in a study during a screening visit | The primary reason to indicate why the potential participant/subject is not enrolled in a study during a screening visi | Primary Reason | Consent withdrawn;No longer eligible;Other, specify | Consent withdrawn;No longer eligible;Other, specify | Alphanumeric |
If not enrolled, choose one. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 16:35:19.49 | Screening Log | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience |
Single Pre-Defined Value Selected |
