Trial Master File Index

Trial Acronym:<insert trial acronym>EudraCT No:<insert EudraCT no.>

TRIAL MASTER FILE - INVESTIGATOR SECTION CHECKLIST

1Administrative

1.1Contact List

/ / /

2Study Protocol

Current protocol signature pages / / /
Superseded protocol signature pages / / /

3Participant Information Sheet And Consent Form

3.1Patient Information Sheet (PIS)

Current Approved PIS on headed paper / / /
Superseded Approved PIS(s) on headed paper / / /

3.2Informed Consent Form (ICF)

Current Approved ICF on headed paper / / /
Superseded Approved ICF on headed paper / / /

3.3GP Letter

Current Approved Letter/Information for Patient’s GP on headed paper / / /
Superseded Approved GP Letter/Information for Patient’s GP on headed paper / / /

3.4Sample Diary Cards (if applicable)

Current Approved Sample Diary Cards on headed paper / / /
Superseded Approved Sample Diary Cards on headed paper / / /

3.5Other Ethics Approved Information Given to Patients

Current Approved Recruitment Advertisement(s) on headed paper / / /
Superseded Approved Recruitment Advertisement(s) on headed paper / / /

3.6Site ARSAC Licence (if applicable)

Completed form, approval letters and updates

/ / /

4Research & Development

Site specific submission documentation and approval letter / / /
Acknowledgment(s) of receipt of amendment documentation and local approval letter for amendments / / /

5Finance and contracts

Signed site agreement / / /
Record of study payments / / /

6Research Team – Staff and Training

6.1Delegation Duties Log

/ / /

6.2Signed & Dated CVs & GCP Certificates for all staff listed on delegation log

/ / /

6.3Study specific training log

/ / /

6.4Out of hours contact test

/ / /

6.5Imaging Transfer test (if applicable)

/ / /

7IMP Section

7.1Acknowledgment of receipt of Investigator Brochure and / or SmPC(s) updates

/ / /

7.2Sample IMP Accountability log and approval and completed IMP accountability logs

/ / /

7.3Sample Prescription(s) and approval

/ / /

7.4Decoding/Unblinding procedures (where applicable)

/ / /

7.5Documentation of IMP shipments and receipts

/ / /

7.6IMP return/destruction documentation and procedures

/ / /

7.7Temperature deviation information

/ / /

7.8Lead Pharmacist declaration (where applicable)

/ / /

8Pharmacovigilance

8.1Acknowledgment of receipt of safety notifications to investigators including SUSARs and DSURs

/ / /

9Patient data

Completed screening logs / / /
Completed enrolment logs / / /
Location of CRFs/Source data / / /
Completed sample transfer forms / / /

10Laboratory/technical /medical procedures

Certificate of accreditation / / /
Laboratories Reference Ranges / / /

11Monitoring and Audits

11.1Monitoring

SIVreport and trial open notification / / /
Monitoringreports including pharmacy / / /
Close out visit report / / /

11.2Feasibility documentation

/ / /

11.3Site only audit Certificates

/ / /

12Study Closure

Acknowledgment of receipt of clinical study report / / /
Letter confirming permission to archive / / /
Details of archive arrangements / / /

13Correspondence

JRMO Trial Master File Investigator Section Checklist TemplateV1.0Page 1 of 3