date of visit/assessment
Item
date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Subject initials
Item
Subject initials
text
C2986440 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
how did you learn about this study?
Item
Are you willing to tell us how you learned about this study?
boolean
C0683836 (UMLS CUI [1,1])
C0012625 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
If yes, what is the primary method that prompted the subject's interest in the study?
text
C0205225 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0543488 (UMLS CUI [1,4])
Code List
If yes, what is the primary method that prompted the subject's interest in the study?
CL Item
Clinic patient (site actively reviews patient charts and/or databases and initiates contact with patient) (1)
CL Item
Physician referral (e.g., lunch-n-learn, letter to colleagues, etc.) (2)
CL Item
Referred by family member (3)
CL Item
Referred by study participant (4)
CL Item
Subject-initiated internet search (e.g. discovered findclinicalstudy.com) (5)
CL Item
Other internet provider paid by GSK (e.g., harrisinteractive.com) (6)
CL Item
Information in clinic (e.g., posters, brochure, etc.) (7)
CL Item
Community outreach (e.g., healthfair, advocacy groups, support groups, etc.) (8)
CL Item
Local newspaper advertisement (9)
CL Item
Local radio advertisement (10)
CL Item
Other local paid advertisement (e.g., local television, local direct mail, etc.) (11)
CL Item
Information at daycare (12)
CL Item
National radio campaign (13)
CL Item
National television campaign (14)
CL Item
Other national campaign (e.g., national magazine, national direct mail, etc.) (15)
CL Item
Other, specify (OT)
source of information, other interned provider
Item
if other interned provider paid by GSK, please specify
text
C0683836 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1138603 (UMLS CUI [1,3])
source of information, other
Item
if other, please specify
text
C0683836 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Trial screen failure
Item
Was this subject a screen failure?
boolean
C1710476 (UMLS CUI [1])
Trial screen failure inclusion/exclusion criteria
Item
Yes, did not meet inclusion/exclusion criteria
boolean
C1710476 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1710476 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
Trial screen failure, adverse event
Item
Yes, adverse event (unspecified)
boolean
C1710476 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Trial screen failure, lack of efficacy
Item
Yes, lack of efficacy (unspecified)
boolean
C1710476 (UMLS CUI [1,1])
C0235828 (UMLS CUI [1,2])
Trial screen failure, protocol deviation
Item
Yes, protocol deviation (unspecified)
boolean
C1710476 (UMLS CUI [1,1])
C1705236 (UMLS CUI [1,2])
Trial screen failure, protocol defined stopping criteria
Item
Yes, Subject reached protocol defined stopping criteria (unspecified)
boolean
C1710476 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Trial screen failure, study terminated
Item
Yes, study closed / terminated (unspecified)
boolean
C1710476 (UMLS CUI [1,1])
C2348570 (UMLS CUI [1,2])
Trial screen failure, lost to follow up
Item
Yes, lost to follow up (unspecified)
boolean
C1710476 (UMLS CUI [1,1])
C1302313 (UMLS CUI [1,2])
Trial screen failure, investigator discretion
Item
Yes, investigator discretion
boolean
C1710476 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
investigator discretion specification
Item
if investigator discretion, please specify
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Trial screen failure, consent withdrawn
Item
Yes, withdrew consent
boolean
C1710476 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
Consent withdrawn, specification
Item
if consent withdrawn, please specify:
text
C1707492 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])