Protocol BOPV: Investigator Site File Filing Guidelines

1- STUDY DOCUMENTS
1.1
1.2
1.3
1.4
1.5
1.6
1.7

Investigator's brochure(s) (C,P): versions n

Protocol(s) signed (C,P) versions n
Amendment(s) signed (C,P) n
Operating guidelines / study manual: versions n
Blank case report form / Diary Card (C)
CRF completion Guidelines (C) versions n
Blank subject information and informed consent
form
1.8 Copy of the advertisement and/or the letter used for
subject recruitment
1.9 Signed clinical study report
1.10 Correspondences

Protocol BOPV: Investigator Site File Filing Guidelines

2- FINANCIAL and LEGAL DOCUMENTS
2.1
2.2

2.3
2.4
2.5
2.6
2.7

Confidentiality Agreement
Signed financial agreement (F)
investigator / institution and sponsor
investigator / institution and CRO
Clinical Trial agreement (Ca, US)
Insurance statement (if separate from the trial
agreement)
Signed indemnity statement (if separate from the
trial agreement)
Financial Disclosure Form
Correspondences

Protocol BOPV: Investigator Site File Filing Guidelines

3- REGULATORY DOCUMENTS
3.1
3.2
3.3
3.4
3.5
3,6
3.7
3.8
3.9
3.10
3.11
3.12
3.13

3.14
3.15

Dated, documented approval / favorable opinion

of IRB / IEC on study documents
IRB / IEC composition
IRB / IEC procedures
Regulatory authority authorization / approval / notification
of protocol (+ revisions if applicable)
CV and/or other relevant document evidencing
qualifications of investigator(s) / sub-investigator(s)
Study task delegation and staff signature list
Signed FDA 1572 or Health Canada forms
Opinion of the Conseil de lordre des Mdecins (F)
(C)
Opinion of the viral safety expert board (F) (C,P)
Opinion of the bio molecular engineering
commission research
(DIB) (Phase I) (F)
Authorization of investigational site for biomedical
research (DIB) (Phase I) (F)
Importation license (C,P)
Notification by sponsor and/or investigator to regulatory
authorities
and IRB/IEC of unexpected serious adverse event drug
reactions
and other safety information (C)
Interim and/or final report by the investigator to IRB
or sponsor (C)
Correspondance

Protocol BOPV: Investigator Site File Filing Guidelines

4- MONITORING
4.1
4.2
4.3
4.4
4.5
4.6
4.7

Study initiation visit report

Site visit log
Letter of notification of withdrawal (Ca)
Monitoring Visit Follow Up Reports
CRF Shipping certificate (C) (F)
CRF Transmittal form
Correspondences