The definition of the end of the study should be included in the protocol.

For most studies this will be the date of the last visit of the last participant. The end may also be the completion of any follow up monitoring and data collection as described in the protocol.

The research and development standard operating procedures (SOPs) 14 and 21 are available to help. They explain things such as database lock and trial close down.

Clever close-down checklist

Who?

• All projects hosted and sponsored by TEWV
• Local study team with research and development archivist

Why?

• Legal requirement
• Assurance all steps are complete
• Important to share results

When?

• Study recruitment and follow-up is complete

What?

Data

• Has all data been returned?
• Are all data queries resolved?

Money

• All payments/orders complete?
• All invoices complete?

Share

• Does sponsor/lead team have
• A plan for sharing results?
• What can we do locally?

Archive

• Is all archiving prep complete?
• Have sponsor given go-ahead?

How?

• Use checklist template in close-down SOP to document the above steps
• Use research and development archiving guide and SOP
• Use research and development dissemination guide

Notify key contacts

When a study ends you need to notify the review bodies that originally gave approval for it.

Health Research Authority (HRA) and Research Ethics Committee (REC)

Declare to the REC that gave a favourable opinion within 90 days of the study ending using the appropriate form. For studies with both a REC favourable opinion and HRA approval, you only need to declare the end of the study to the REC.

For clinical trials of investigational medicinal products (CTIMPs), the same end of trial form is used to notify both REC and the Medicines & Healthcare products Regulatory Agency (MHRA). The form you will use depends on how your trial was submitted. Our research and development team will be able to talk you through this.

For all studies except CTIMPs, the declaration of end of study form available on the HRA website should be used.

Notifying the MHRA

For CTIMPs the declaration of end of trial must be sent to MHRA within 90 days of the global end of the trial date.

Notifying other bodies

If you needed approval from any other bodies, please check if they have any end of study reporting requirements. An example of this might be the confidentiality advisory group. Check with our team at the relevant time if you are unsure.

Informing participants

People who have taken part should be thanked for their contribution and told when they can expect the findings. A summary of the research findings could be provided which acknowledges and respects the contribution they have made.

Data lock and final payments

Database lock is the last step in the data management and is usually the responsibility of the trial management team. The chief investigator, statistician, and sponsor may all contribute too.

The final analysis of the data following lock of the study database usually happens after formal declaration of the end of the study.

Databases are locked at the point when:

• All reasonable attempts have been made to collect all outstanding data items and
• Any data queries have been resolved.

You should ensure that all members of the study team and your sites have been notified of the date of lock.

Final payments

If your study involves payments to other organisations, you should contact our research and development team to ensure all monies are paid out appropriately. It is important to consider whether the sites have completed their close down work. Examples of this would be resolving any data queries and returning any equipment.

Archiving

All data and essential documents must be archived in accordance with research and development SOP 11 and any applicable regulations. This applies to all studies, irrespective of the format, either electronic or paper.

Snappy archiving SOP

Disclaimer: This does not mean you do not have to read the actual SOP

Who?

• All staff involved in research
• All projects hosted and sponsored by TEWV
• Named archivist: research and development manager

Why?

• Legal requirement- we have to show we adhere to GCP and local SOPs, GDOR

What?

• Docs included in TMF, pharmacy records, data management and sponsor correspondence
• Prepare: assess contents – what can be disposed of? Will anything
• Deteriorate?
• Separate studies in separate boxes
• Remove paperclips, lever binders, metal fixings, plastic wallets, rubber bands etc
• Remove all personal identifiers except for consent forms and
• Screening/enrolment logs
• Source data only if not part of med records (otherwise add filenote)
• Electronic data:
  • Store on server or CD (not USB or memory drives!) Paper copy if possible
  • Must be duplicated and stored in separate locations!

How?

• Minimum five years after study closes (or as per protocol)
• Inform archivist – email [email protected]
• Collect all sources
• Label correctly: see archive form – 1 form per box
• Arrange transfer to Flatts Lane Centre medical records (restore)

For CTIMPs, it is a legal requirement that the study sponsor appoints a named individual within the organisation to be responsible for archiving the documents. This person will be based within the research and development department.

The research and development department will support and advise on preparation for archiving and how long the documents should be stored. For many studies this is often up to five years following study completion. However this period of time can be longer if this has been agreed with the sponsor. Also some study types, such as CTIMPs, have much longer minimum archiving periods.

It is important to archive data, even if you do not plan to share it with others.