patient completed planned observation time
Item
1. The patient completed planned observation time according to protocol
boolean
C0525058 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
2. If no please specify why:
integer
C2348235 (UMLS CUI [1])
Code List
2. If no please specify why:
CL Item
Death (must me recorded on death form) (1)
CL Item
Adverse Event (explain below) (2)
CL Item
Non compliant with protocol (explain below) (3)
CL Item
Lost follow-up (explain below) (4)
CL Item
Consent withdrawn (not due to adverse event, explain below) (5)
CL Item
Other (explain below) (6)
Explanation
Item
Explain:
text
C0681841 (UMLS CUI [1])
Invenstigator´s Declaration
Item
3. Invenstigator´s Declaration By signing and dating this page, I declare that I have reviewed for accuracy all case report form pages for this patient; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed in the dates specified.
text
C0008961 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Investigator´s signature
Item
Investigator´s signature
text
C2346576 (UMLS CUI [1])
Date of Signature
Item
Date of Signature
date
C0011008 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])