Longterm followup ownership and retention of data

A further benefit of an established trials centre with core-funded staff is that it provides a natural 'home' for trial data, both electronic and paper-based, to be retained in the long term. Issues to be aware of in this respect include the need to:

♦ continue long-term follow-up of trial patients,

♦ retain data securely for a specified period after completion of a trial as required by GCP,

♦ provide access to trial data for relevant research projects including systematic reviews and meta-analyses, which may happen as many as twenty years or more after the trial was completed.

Where funding for an individual trial is attached to a person - perhaps the principal investigator - rather than an institution or group with a long-term commitment, all these issues can be problematic. It is difficult to secure funding for long-term follow-up of trials when individual trials are grant-funded, whereas it is likely to be easier to justify as part of a rolling programme of trials. It may also be unclear who is responsible for trial data should the principal investigator move or change jobs. It is therefore important to ensure that guidelines with respect to these issues are produced at an early stage.

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