Close Down Overview
We’re working on this section. For now, have a look at:
- The UK has a big network of trial managers, the UK Trial Managers’ Network. It has produced a free guide to efficient trial management.
- There is a free tool to support trial management, called, imaginatively, the Trial Management Tool is one of many tools available from one of the Norwegian Cochrane sites. Scroll down to get the to Trial Management Tool. It’s getting a bit old now but has some useful material in it.
Top 5 Close Down Tips
01.
If your trial has formal early stopping rules, then it’s important that an early termination plan is put in place at the start of the trial.
02.
The evidence available to inform many trial management decisions, including close down, is very thin. If you are uncertain about a decision, consider initiating or joining a Trial Forge evaluation of the options you are considering.
03.
More to come: keep checking the site…
04.
More to come: keep checking the site…
05.
More to come: keep checking the site…
More About Close Down
According to Good Clinical Practice, the close down of a clinical trial can only be done when both investigator/institution and sponsor files have been reviewed, and it has been confirmed that all necessary trial-related documentation have been completed. The proposed end date of a trial is determined by the study protocol; the protocol should also detail specific circumstances or events which may warrant an early termination date. At this stage all data queries should have been resolved, statistical analysis and interpretation of results completed, and reports written for funders, sponsors, relevant ethics committees and regulatory authorities. Documentation should be archived according to protocol and sponsor policy.
