Topic outline

Concept of Study Documentation

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This topic describes the process for documenting a clinical trial. This includes:
  • How all documentation generated for a study (at the site of the investigator and of the sponsor) gets compiled for a potential inspection by the competent authorities.
  • How the data is collected.
  • Where the data is recorded by the investigator.
A clinical trial is organised to generate information to enhance the knowledge about a new or existing treatment. Information means data. The quality of the data needs to be good to ensure that the conclusions drawn from this data are reliable. Therefore, data collection, handling and storage needs to be controlled. This means that there must be a process in place that ensures reliable data collection and control. In clinical trials, ‘source documents’ and ‘case report forms’ (CRFs) are used for this purpose.

Investigator Brochure

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An Investigator’s Brochure (IB) is a compilation of data on the investigational medicinal product (IMP) (the medicine being studied) which is relevant to the study of this product in humans. It includes clinical and non-clinical data, i.e. any data from studies with patients (clinical) and data from other sources such as laboratory tests (non-clinical).

The purpose of the IB is to provide the investigator and others (e.g. clinical trial coordinators, study nurses) with background information to help them work in line with the protocol.

  • The IB is prepared by the sponsor. They also control the distribution of the document. This is because it is the single most comprehensive document summarising the properties of the IMP.
  • It provides the clinician or potential investigator with information they need to assess the appropriateness of the trial, including the benefit-risk relationship. It allows them to do this in an independent and unbiased way.
  • It provides insight to support the clinical management of study participants during the clinical trial. This includes information about doses, dose frequency, methods of administration and safety monitoring procedures.
  • The IB is submitted with the Clinical Trial Application (CTA). This is sent to the Competent Authority for approval.

Patient Reported Outcomes (PROs) and Data Collection

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Basics of Quality Management in Clinical Trials

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Project Management in Clinical Trials

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Assessment

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