Title page of a protocol

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Title page of a protocol should have the following:

 Name and address of sponsor(s).

 Name, title, address and telephone number of the Chief Investigator.

 Name, address, title and telephone number of all other Investigator(s).

 Name, title, address and telephone number of trial monitor

 Address and telephone number of study site(s), including extension numbers, where relevant.

 Name, title, address and telephone number of the qualified physician who is responsible for all study related medical decisions (if different to the investigator).

 Names and addresses of the clinical laboratories and other medical and/or technical departments and/or institutions involved in the study.

Protocol details

 Version number and date, e.g. v2 29/05/2010.

(any amendments should bear the amendment number)

Marked Confidential

The title page is usually followed by a list of abbreviations and operational definitions.

Smita