Subject identification number
Item
Subject identification number
text
C2348585 (UMLS CUI [1])
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C0008976 (UMLS CUI [1,1])
C1549507 (UMLS CUI [1,2])
C0422727 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Item
Was the patient withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Code List
Was the patient withdrawn from the study?
CL Item
Yes, complete primary reason for withdrawal (Y)
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Primary reason for withdrawal
CL Item
Adverse Event (record details on the Non-Serious Adverse Events or Serious Adverse Events from as appropriate) (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Lost to follow-up (6)
CL Item
Investigator discretion, specify (Select this reason if none of the other primary reasons are appropriate) (7)
CL Item
Withdrew consent (8)
Reason for withdrawal: investigator discretion, specify
Item
If investigator discretion, specify
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
CL Item
PF_SC_SPONSORDECISION (?)
CL Item
PF_SC_PHYSICIANDECISION (?)
CL Item
PF_SC_PATIENTDECISION (?)
CL Item
PF_SC_CRITERIA (?)
Item
Was the treatment blind broken during the study?
text
C3897431 (UMLS CUI [1])
Code List
Was the treatment blind broken during the study?
CL Item
Yes, complete date and reason (Y)
Date blind broken
Item
If yes, complete Date blind broken
partialDatetime
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If yes, complete Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
If yes, complete Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (Z)
Other reason blind broken
Item
If yes and Other reason, specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Has the subject withdrawn consent for PGx research?
text
C1707492 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Code List
Has the subject withdrawn consent for PGx research?
CL Item
Yes, provide date (Y)
Date informed consent withdrawn
Item
If yes, provide date informed consent was withdrawn
date
C1707492 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Has a request been made for saliva sample destruction?
text
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0438730 (UMLS CUI [1,3])
Code List
Has a request been made for saliva sample destruction?
CL Item
Yes, check reason (Y)
Item
If yes, check reason
text
C0566251 (UMLS CUI [1,1])
C1272683 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0438730 (UMLS CUI [1,4])
Code List
If yes, check reason
CL Item
Subject withdrew consent for PGx (3)
CL Item
Other, specify (Z)
Other reason for request of saliva sample destruction
Item
It other reason, specify
text
C0566251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C1948029 (UMLS CUI [1,4])
C0438730 (UMLS CUI [1,5])
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Code List
Did the subject become pregnant during the study?
CRB Electronic Signature Affidavit
Item
By my dated signature below, I, [First Name] [Last Name], verify that all case report form pages accurately display the results of the examinations, tests, evaluations, and treatments performed on this patient. Pursuant to section 11.199 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
text
C2346576 (UMLS CUI [1])
CRB Electronic Signature Affidavit Date
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Name of Investigator (CRB)
Item
Name of Investigator (CRB)
text
C2826892 (UMLS CUI [1])
CRF Electronic Signature Affidavit
Item
By my dated signature below, I, [First Name] [Last Name], verify that all case report form pages accurately display the results of the examinations, tests, evaluations, and treatments noted within. Pursuant to section 11.199 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
text
C2346576 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
CRF Electronic Signature Affidavit Date
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Name of Investigator (CRF)
Item
Name of Investigator (CRF)
text
C2826892 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])