Trial documents

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3.2 Trial documents EXAMPLE OF DOCUMENTS PREPARED BEFORE THE START OF THE TRIAL	BACK
Hospital information & PI CV	To provide information about the trial site, key staff working on the trial and CV of the principal investigator to assess site suitability for the trial.
Principal Investigator Agreement	It is necessary to sign and return this form before trial materials can be sent to trial site.
Trial responsibilities agreement for national co-ordinators	In each country a National Coordinator (Chief Investigator in the EU) is responsible for the trial in their country. Trial related responsibilities are delegated as necessary.
Financial agreement	An agreement about how the investigator's trial related costs will be covered.
Indemnity	An insurance policy stating that LSHTM accepts responsibility attached to its sponsorship of the study and, as such, would be responsible for claims for any non-negligent harm suffered by anyone as a result of participating in this study.
Section J checklist	A list of required documents for regulatory and ethics submission in the EU countries.
Other relevant countries' ethics opinion / regulatory approval	May be required to support applications in some countries, especially in the EU.
Investigator's study file	Kept at each trial site and contains all trial related information and spare forms. All documentation collected during the trial, such as case report forms, signed consent forms and correspondence are also stored in the site file.
Site delegation of responsibility log	List of all persons, and their signatures, in the trial site who have a role in the trial.
Investigator's brochure	Contains all information currently known about the trial drug. It is intended to allow the investigator to make an objective, unbiased decision about taking part in the trial and to use as a point of reference during the trial.
SmPC	Manufacturer's Summary of Product Characteristics. This is required for most countries' regulatory approval applications.
Drug accountability	The investigator is responsible for keeping a record of all treatment packs stored at his/her trial site, from receiving them from the coordinating centre, to using them to treat trial participants, to destroying them either at expiry or at the end of the trial as advised by the coordinating centre.
Patient screening	All eligible patients should be recorded and a reason given for not randomising. The aim is to demonstrate that a reasonable number of patients were considered for the trial and to identify specific problems with randomisation e.g. a particular exclusion criteria that frequently causes patients not to be included.
Patient information leaflets and consent forms	In the EU these (and the Legal Representative forms) are printed on the hospital letterheaded paper with the investigator's contact details. Translations should be provided for anywhere in the world. A core text is provided which the ethics committees may amend according to local regulations.
Patient randomisation log	The coordinating centre is not collecting patient identifiable data. It is mandatory that the randomisation log contain sufficient information to ensure all randomised patients can be traced.
Draft letter to patient's primary care doctor	Patient's family doctor needs to be informed of the patient's participation in the trial. The letter can be amended to suit local circumstances.
Case Report Forms for data collection	Used by the investigators to record all required information about the patient and the outcome of the treatment.
Adverse event reporting guidance / reporting form	Guidance for reporting is provided, but investigators should also follow regulations in their own country.
Data discrepancy	Trial data is constantly monitored for consistency and correctness. If any serious discrepancies are found the coordinating centre will ask the investigator to complete a data discrepancy form.
Source data verification	Periodically the coordinating team will make site audits and verify a percentage of all trial data to ensure data quality and compliance with ICH GCP.
Site visit log / Site visit report	Completed together by the investigator and the member of the coordinating team making the site visit.
Trial master file	Kept at the coordinating centre and contains all documentation relevant to the trial. The final approved version of the patient information leaflet and consent form must be submitted to the coordinating centre, to be kept in the trial master file.

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