CDE Detailed Report

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

Displaying 1 - 17 of 17
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
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 that the potential participant/subject is not eligible for a study. 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

C00007 Birth date BirthDate Date (and time, if applicable and known) the participant/subject was born Date (and time, if applicable and known) the participant/subject 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 3.00 2013-07-25 08:54:08.2 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 number identifying the protocol or study. 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

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 that the potential participant/subject is not enrolled in a study during the screening visit. 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

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. 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

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 study. 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

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 study. 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

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 visit. 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

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

C17399 Global unique identifier number GlobalUniqueIdNum Global Unique ID (GUID) which uniquely identifies a subject Global Unique ID which uniquely identifies a subject 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 3.00 2013-07-18 14:26:06.9 Screening Log Participant/Subject Identification, Eligibility, and Enrollment Protocol Experience 255

Free-Form Entry

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

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

CSV