Best Practice for … Clinical Monitoring

3 Key Documents in Clinical Trials / Documents to Know

In this chapter you will learn:
• What informaKon is crucial to know?
• Where can I find this informaKon?
• What are good study documents?

3.1 PROTOCOL

According to ICH-GCP 1.44 a protocol is: “A document that describes the objecnve(s), design, methodology, stansncal consideranons, and organizan- on of a trial. The protocol usually also gives the background and ranonale for the trial, but these could be provided in other protocol referenced documents.” For a clinical monitor the protocol is his basic manual. In the protocol the clinical study is explained in detail in several secnons. These secnons are quite standardized from protocol to protocol, since they are outlined by the Internanonal Conference of Harmonizanon. In general the following secnons are used: General Informanon, Background Informanon, Trial Objecnves and Purpose, Trial Design, Selecnon and Withdrawal of Subjects, Treatment of Subjects, Assessment of Efficacy, Assessment of Safety, Stansncs, Direct Access to Source Data/Documents, Quality Control and Quality Assurance, Ethics, Data Handling and Record Keeping, Financing and Insurance, Publicanon Policy, Supplements (annexes).

You have to read and understand the protocol thoroughly, as you will have discussions with the invesngator later on. Furthermore, youwill need to train or oversee the training of the site personnel on the study treatments, so during the ininanon phase of the trial youwill need to be an expert on the protocol. Of course your company also has the obliganon (ICH-GCP secnon 5.18.2) to train you on the protocol and especially on the indicanon, the conduct of the trial and the relevant stansncal consideranons.