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• Trials that Began Before 1st May 2004
• Planning a New Trial

  • Research Question

  • Is the trial within the scope of the UK Regulations?

  • Sponsorship

  • Protocol Development

  • GCP (Management and Monitoring)

  • Trial Documentation

  • Trial Supplies

  • Pharmacovigilance

  • R&D Consultation

  • Funding Proposal (if required)

  • Peer Review

  • Funding Secured

  • Trial Master File

  • Unique Trial Number

  • Obtain EudraCT Number

  • Identify Sponsor(s)

  • Final Protocol

  • CI Checklist before seeking approvals

  • R&D Submission

  • Ethics Submission

  • CTA Submission

  • Approvals and Permissions Obtained

  • Final Trial Management Documentation

• Trial Management and Closure

GCP (Management and Monitoring)

The EU Clinical Trials Directive requires clinical trials to be conducted according to the principles of Good Clinical Practice (GCP). The standards are specified in a separate EU Commission Directive on GCP; see below for GCP Directive.  The GCP Directive was implemented into UK Statute by the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006.  A specific modality for non-commercial trials is being produced, we will provide a link to the finalised document once published.

Good Clinical Practice is defined as "a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected"(ICH GCP).

The UK Regulations require that all trials within their scope adhere to the principles of GCP.

It is recommended that researchers develop procedures and systems for trial management that meet the principles of GCP, and that these are clearly documented so that adherence is readily demonstrated.

MHRA accepts in principle that a risk-based approach to trial management and monitoring is appropriate.

The remaining documents are to assist researchers in developing systems for management and monitoring of their trial, appropriate to the trial design and the associated risks to trial participants and data quality.

It is recommended that researchers develop procedures and systems for trial management that meet the principles of GCP, and that these are clearly documented so that adherence is readily demonstrated.

For each clinical trial a risk assessment should generally be undertaken at the protocol development stage. This may be used to plan the details of trial management and the approach to, and extent of, monitoring in the trial. These plans should be documented, together with the risk assessment, so that the management strategy is both transparent and justified. This documentation is intended not only to facilitate the management of the trial but also to help prepare for external audit.

Thus for each trial there would be:

1. a clinical trial risk assessment
2. a summary of trial management systems
3. procedures for monitoring

These would not necessarily be separate documents and may be included in the protocol or in standard operating procedures.

If you are working in an organisation that hosts a number of trials you may be interested in the final three documents, which examine research management systems for institutions that manage a portfolio of trials.

The EU Commission consulted on the specific modalities for non-commercial trials, see the joint response to this consultation and additional comments on monitoring.

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