Clinical Trial Documentation

Question 1

ISF or TMF or Both: Sample of Label attached to IMP

Answer 1

TMF

Question 2

ISF or TMF or Both: Certificates of Analysis for IMP shipped

Answer 2

TMF

Question 3

ISF or TMF or Both: Master Randomization List

Answer 3

TMF

Question 4

ISF or TMF or Both: Pre Trial Monitoring Report

Answer 4

TMF

Question 5

ISF or TMF or Both: Site Initation Report

Answer 5

TMF and ISF

Question 6

ISF or TMF or Both: Monitoring Visit Reports

Answer 6

TMF

Question 7

ISF or TMF or Both: Signed ICFs

Answer 7

ISF

Question 8

ISF or TMF or Both:Source Documents

Answer 8

ISF

Question 9

ISF or TMF or Both: SIGNED, DATED AND COMPLETED
CASE REPORT FORMS (CRF)

Answer 9

Both. Original: TMF, Copy: ISF

Question 10

ISF or TMF or Both: Documentation of CRF Corrections

Answer 10

Both. Original: TMF, Copy: ISF

Question 11

ISF or TMF or Both: Subject Identification Log

Answer 11

ISF

Question 12

ISF or TMF or Both: Subject Enrollment Log

Answer 12

ISF (generally both if there is no identifying information)

Question 13

ISF or TMF or Both: Clinical Study Report

Answer 13

Both (sometimes ISF not applicable)

Question 14

Important elements of source (9)

Answer 14

• Consent process
  
  • Documentation of subj eligibility
  • Study randomization
  • Completion of all protocol required tests, procedures or examinations
  • Study drug adherance
  • Subjects contacts via phone or in person
  • Missed visits with justification
  • Protocol deviations and actions taken
  • Adverse events details

Question 15

FDA 1572

Answer 15

Agreement signed by the PI to provide certain information to the sponsor and comply with FDA regulations related to the conduct of clinical investigations under US IND