undertaking by investigators

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Trial Conduct

The protocol should have a statement mentioning that the study will be performed in compliance with the protocol, GCP and the applicable regulatory requirement(s)/ principles stated in the Declaration of Helsinki.

Undertaking by Investigator

Each clinical trial protocol should have an “Undertaking by Investigator†which should contain the following information:

1. Full name, address and title of the Principal Investigator

2. Name and address of the medical college, hospital or other facility where the clinical trial will be conducted: Education, training & experience that qualify the Investigator for the clinical trial (Attach details including Medical Council registration number, and / or any other statement(s) of qualification(s))

3. Name and address of all clinical laboratory facilities to be used in

the study.

4. Name and address of the Ethics Committee that is responsible for approval and continuing review of the study.

5. Names of the other members of the research team (Co- or sub-Investigators) who will be assisting the Investigator in the conduct of the investigation (s).

6. Protocol Title and Study number (if any) of the clinical trial to be conducted by the Investigator

7. Signature with Date

In addition to the above information the “Undertaking by investigator†should also include the following commitments by the Investigator:

i. Study not to begin until EC / DCGI approval

ii. Adherence to protocol

iii. Personal supervision

iv. Ensure requirements of EC review

v. Report of AE to sponsor

vi. Understanding of investigator’s brochure

vii.Ensure that all associates, colleagues and employees are suitably qualified and experienced and aware of their obligations

viii. Maintenance of records and availability for audits / sponsor inspection / EC and DCGI ;ation in audits

ix. Report to EC promptly about changes and unanticipated problems

x. Report all unexpected serious adverse events to the Sponsor in 24 hrs and EC within 7 days

xi. Confidentiality of data and patients

xii. Compliance with all other obligations of clinical investigators

Dr. Smita

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