Setting Up Clinical Studies

To ensure that the standards for clinical research are established before studies begin and to check on compliance with those standards, many fundamental systems and processes must be defined by pharmaceutical companies and contract research organizations (CROs). These are outlined in Table 8.1.

The sponsor/CRO has a duty to place a study safely. That is, the sponsor (or the delegated CRO) must assess and choose a site where study subjects will not be harmed. Some companies report that, in practice, they have little choice in this process, as the marketing department has already selected the

Table 8.1 General systems and procedures for implementation of GCP

The following systems and procedures must be established by clinical researchers to ensure compliance with GCP requirements:

Quality assurance: systems for assuring quality and for checking quality must be established and followed at all stages Planning: studies must be conducted for valid (ethical and scientific) reasons

Standard operating procedures ( SOPs) : research procedures must be declared in writing so that reviewers can determine the standards which are being applied and so that users have a reference point Well-designed study: all studies must have a valid study design, documented in a protocol, so that it can be fully reviewed by all interested parties. The data collection plans, as described in the CRF, are part of the protocol Qualified personnel: all personnel (sponsor/CRO and study site) must be experienced and qualified to undertake assigned tasks.

Documentation of qualifications and training must be evident Ethics committee review and approval: all studies must be independently reviewed by ethics committees/IRBs, to assess the risk for study subjects, before clinical studies begin. Review must continue throughout the study Informed consent: all study subjects must be given the opportunity to personally assess the risk of study participation by being provided with certain information. Their assent to participate must be documented Monitoring: a primary means of quality control of clinical studies involves frequent and thorough monitoring by sponsor/CRO personnel

Data processing for integrity of data: data must be honest. Data must be reviewed by site personnel, monitors and data processing personnel

Control of study medications/devices: the product being studied must be managed so that study subjects ultimately receive a safe product and full accountability can be documented Archives: documentation of research activities must be securely retained to provide evidence of activities investigators (often those most likely to influence use of the medications/devices). Another rationale for apparent lack of choice is that there are too few patients or investigators in a particular therapeutic area. None of these reasons is as important as compliance with the basic GCP principle, which requires the sponsor/CRO to assess, select and choose safe settings for research.

Setting up clinical studies is a lengthy process, as there are many documents to prepare [e.g. protocols and case report forms (CRFs) ], study facilities to be assessed (e.g. study sites, CROs, clinical laboratories, Phase I units), regulatory review to be considered, and negotiations and agreements with study sites (e.g. contracts, finances, confidentiality, indemnity, insurance) to be undertaken. In addition, as will be dealt with in subsequent sections, ethical aspects of the study must be considered (e.g., ethics committee and IRB review and informed consent requirements) and study medications/devices must be organized.

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