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Closing a Study
There are several steps that need to be undertaken when a study is closed. Some of the most important elements relate to the records from the study, and any unused drugs that were produced by never administered in the course of the study. With respect to record-keeping, all studies keep meticulous records, but also have a duty to ensure the privacy of the people who were involved in the study. This duty exists even after the study is discontinued; the obligation to protect patient privacy remains. Moreover, the company should want to keep the records safe simply for its own interests, as there may be important knowledge contained in those records that can be of use at a later date.
In general, records need to be kept for a fairly long period of time. For example, the records of the patient codes need to be kept for 15 years. Other data, such as patient files, may be kept for a length of time as determined by the institution where the trial took place. Thus, that information may be kept for less than 15 years, or more, depending on what the policy of the particular institution is. The files should be kept at an office of the investigator...
The files must always be held at a security facility in order to maintain patient privacy. To ensure this, there should be excellent record-keeping of the files, so that boxes are labeled and entered into a database. This will enable the institution that conducted the trial to track the files at all times, ensuring that they remain safely stowed. Any change of custody must be documented, such as if a third-party shipper is used to transport the records to off-site storage.
When the mandatory holding period for documents relating to the trial has passed, there are stipulations regarding the safe disposal of these documents. They cannot, for example, simply be dumped in a landfill. Proper disposal means that the documents need to be shredded before they are submitted to a dump or recycling facility. It is recommended practice to have digital copies, even if the records are to be shredded, and those copies under secure storage.
The handling of drugs after a trial has been discontinued is also important. All drugs must be…
References
EFGCP (2011). Guidelines for retention of clinical trial records at investigator study sites. EFGCP. Retrieved October 18, 2015 from https://gcprma.files.wordpress.com/2011/07/retention-at-inv-sites.pdf
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