Screening and Enrollment Log. List of all subjects screened and all subjects screened and enrolled in the study.

Transcription

1 Contents Screening and Enrollment Log... 2 Regulatory Approval... 3 Protocol, Amendments and Signature Pages... 4 Investigational Product Information Investigational Product Information Investigational Product Accountability... 7 Unblinding Procedure... 8 FDA Form Curriculum Vitae Professional Licenses Training Delegation of Responsibility Log Sample CRFs and Signature Pages Sample Source Documents Financial Agreements Financial Disclosures Insurance Statement IRB Approval Letters and Submission Forms IRB Approved Consent Forms IRB Approved Subject Materials IRB Approved Recruitment Materials IRB Roster Normal Lab Ranges Lab Certifications CLIA Certification Biological Specimens DSMB Protocol Deviations / Violations AEs / SAEs UAPs IND Safety Reports Additional Safety Information Sponsor Monitoring Reports Study Results

2 Screening and Enrollment Log List of all subjects screened and all subjects screened and enrolled in the study. 2

3 Regulatory Approval For FDA regulated studies, the IND / IDE / study approval. 3

4 Protocol, Amendments and Signature Pages Protocols and amendments including the signature pages signed by the PI and, as applicable, the sponsor. This section is not for the IRB submission forms. 4

5 Investigational Product Information - 1 Package Insert / Investigator's Brochure / Device Manual and if applicable, certificate(s) of analysis and sample investigational product labels. 5

6 Investigational Product Information - 2 Instructions for storage and dispensing of investigational product and related materials if not in protocol or investigator's brochure. 6

7 Investigational Product Accountability At the study level, documentation of receipt, storage, shipping, return and destruction of the investigational product and related materials (e.g. clinical supplies log). 7

8 Unblinding Procedure For blinded studies, the procedure for unblinding a subject if not in the protocol. 8

9 FDA Form 1572 For FDA regulated studies, the Statement of Investigator Form

10 Curriculum Vitae CVs of all investigators and key personnel. 10

11 Professional Licenses Professional licenses of all investigators and key personnel as applicable. 11

12 Training Logs and certificates documenting all study related training. 12

13 Delegation of Responsibility Log List of all study team members and their study responsibilities. 13

14 Sample CRFs and Signature Pages Sample CRFs including the signature pages signed by the PI and, as applicable, the sponsor. If these are to be completed by the subjects, they should be IRB approved and have IRB approval stamps. 14

15 Sample Source Documents Sample source data collection documents. 15

16 Financial Agreements Financial agreements with the sponsor, Medicare Coverage Analysis and other financial agreements. 16

17 Financial Disclosures Disclosure by the investigators of any financial interest or arrangement with the sponsor or related to the investigational product(s). 17

18 Insurance Statement Documentation of compensation to subjects as a direct result of study participation. 18

19 IRB Approval Letters and Submission Forms IRB approval letters and all IRB forms for each initial submission, amendment, continuing review, final report, etc. These should include the signed forms submitted to the IRB and, as applicable, the approved/signed forms returned by the IRB (e.g. OHR-12B and OHR-12C). Keep all the documents for each submission together. 19

20 IRB Approved Consent Forms IRB approved consent forms with the IRB approval stamps. 20

21 IRB Approved Subject Materials Subject materials with the IRB approval stamps. 21

22 IRB Approved Recruitment Materials Advertisements and recruitment materials with the IRB approval stamps. 22

23 IRB Roster Rosters of the IRBs that approved the initial study and subsequent submissions. 23

24 Normal Lab Ranges The normal ranges for the lab tests being performed for the study. 24

25 Lab Certifications The certification / accreditation for the lab(s) being used for the study. 25

26 CLIA Certification The CLIA (Clinical Laboratory Improvement Amendments) Certification for the lab area(s) where specimens are processed. 26

27 Biological Specimens Documentation of specimen collection and shipment. 27

28 DSMB Data Safety Monitoring Board information, plans and reports. 28

29 Protocol Deviations / Violations At the study level, documentation of protocol deviations / violations. See instructions in OHR Policy GA 120 for reporting SAEs and UAPs to the IRB. Protocol deviations / violations, SAEs and UAPs must also be reported to the sponsor per protocol. IRB and sponsor approval/acknowledgement of protocol deviations / violations should also be stored in this section. 29

30 AEs / SAEs AE / SAE reports submitted to the sponsor. 30

31 UAPs Unanticipated Problem Reports (UAPs) submitted to the IRB. 31

32 IND Safety Reports IND safety reports and when necessary, documentation that the information has been received by the IRB. 32

33 Additional Safety Information Additional risk information including changes to the risk profile of the investigational product. 33

34 Sponsor Monitoring Reports Sponsor monitoring reports and any responses or corrective action plans. 34

35 Study Results Interim and final study results (e.g. progress reports, clinical trial reports, final reports, publications, presentations). 35