BGDO | Belgian Group of Digestive Oncology

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Registry documents

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Section 1: Site Personnel

Section 2:  Protocol and Amendments
2.1. Protocol.
- protocol version 3.0 dd 5.10.11
- Synopsis Fr - Nl
- protocol version 2.0 dd 15.10.10

2.2. Signed amendment(s).
- substantial amendment 3 dd 5.10.11
- substantial amendment 2 dd 4.7.11
- amendment 1 dd 15.10.10

Section 3: Independent Ethics Committee
3.1. Leading EC approval(s)

-
Approval LEC St-Luc DNET
Approval amend 3
-  Approval amend 2
-  Approval amend 1

3.3. Notifications & Confirmation of receipt Notification ICF v3

Section 4: Regulatory Documentation
Competent Authorities

Section 5: Subject Documentation
5.1. Signed Informed Consent Forms.

5.2. IEC approved Subject Information/Informed Consent Form.
-  Informed Consent Form v3.0 dd 16Oct2012 in Dutch and French
5.3. Subject Identification List. Subject identification list
5.4. Insurance Certificate. insurance certificate

Section 6: Communication
File the communication.

Section 7: Agreements & Contracts

Section 8: CRF
1. eCRF
2. Paper CRF to use as reference
3.FAQ

 

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