Skip to main content

You are here

End of Study

end of study

The definition of the end of study should be clearly documented in the research protocol1; it should refer to the point of final data capture (the point at which all required data has been collected to answer the research question(s) in the protocol).  For clinical trials this is usually defined as the date of last patient last visit (LPLV).

Occasionally a clinical trial must terminate earlier than specified in the protocol, in these circumstances the relevant bodies will need to be notified in the required timeframes.

If the Chief Investigator plans to extend the research beyond the agreed proposed end date this should be discussed with the Noclor Sponsor Representative (where a Noclor partner is the sponsor) as an extension may require variation to contract(s) and notification to Research Ethics Committee (REC).

Notify the end of study

Within 90 days of the research study concluding as defined in the protocol the Chief Investigator (as delegated) must notify the appropriate bodies that the research has ended. The table below summarises the end of study notifications that are required.

REQUIREMENTS FOR NON-CTIMPs2 REQUIREMENTS FOR CTIMPS

The Chief Investigator should notify the Noclor Sponsor Representative that the study has concluded as defined in the protocol.

The Chief Investigator should notify the Research Ethics Committee (REC) within 90 days of the study conclusion by submitting a Declaration of the End of Study Form.

The Chief Investigator should send a copy of the end of study declaration to the Noclor Sponsor Representative.

The Chief Investigator should notify the funder and all participating sites (as relevant).

The end of study declaration and all related correspondence should be retained in the Study/Trial Master File (S/TMF).

The Chief Investigator should submit a summary study report to the sponsor and REC within 12 months of the declaration of end of the trial.

The Chief Investigator should notify Noclor of all publications resulting from the research.

The Chief Investigator must notify the Noclor Sponsor Representative that the study has concluded as defined in the protocol.

The Sponsor (or  authorised sponsor contact) will  notify the MHRA within 90 days of the date of conclusion by submitting a Declaration of the End of a Clinical Trial form (CTIMP)3

The Chief Investigator must notify the Research Ethics Committee (REC) within 90 days of the date of conclusion by submitting a Declaration of the End of a Clinical Trial form (CTIMP)4

The Chief Investigator should notify the funder and all participating sites.

The end of trial declaration and all related correspondence should be retained in the Trial Master File (TMF).

The Chief Investigator should submit a clinical trial summary report to the sponsor, MHRA and REC within 12 month of the declaration of end of the trial.

The Chief Investigator should notify Noclor of all publications resulting from the research.

[2] Medical Device studies - manufacturers are required to notify the MHRA when a clinical investigation comes to an end.

[3] Once the declaration of the end of a clinical trial form has been received by the MHRA it is not possible to submit any further amendments to the trial, only the end of trial study report will be accepted.

[4] The same declaration of end of trial form should be submitted to both REC and MHRA (authorised signatories in both E2 and E3)

Fulfil commitments to participants

When a research study has concluded the Investigators (Chief and Principal(s)) are responsible for ensuring that the commitments made to their participants are fully met.

The protocol, Participant Information Sheet (PIS) and consent form approved by the Research Ethics Committee (REC) should clearly explain what study participants are to expect once their participation in the research study is complete.

Researchers (as delegated by the Principal Investigator) are responsible for explaining what will happen to participants once they have finished the research during the informed consent process.

At the end of study participants should be thanked for their time and their very valued contribution to research and reminded of the following (relevance will be dependent on study type):

  • what happens to their data and samples
  • their treatment and care post-participation
  • how the results will be disseminated to them
Close-out

Once a study has officially come to an end work should begin to close-out the study ready for final data analysis, reporting and archive.

The close-out requirements of a study should be considered at the planning stage of the research (to ensure that any cost implications are considered).

Noclor may request (as a condition of sponsorship declaration) that study specific standard operating procedures and/or checklists are developed to incorporate close-out plansi.  The close-out should provide assurances to the sponsor that the study has been conducted in accordance with the protocol, GCP and any study specific procedures to produce reliable outcome data.

CTIMPs sponsored by a Noclor partner will have either a site close-out visit or remote close-out conducted and reported for all participating sites (as detailed in the study specific monitor plan).

Some of the following should be considered when closing down a study:

  • notifying all participating sites of the end of study- sending the end of study declaration form and acknowledgement with instruction on close out procedures
  • checks that all data have been correctly completed and all data queries have been resolved so that data can be locked ready for analysis
  • checks on Study/Trial Master File/Investigator Site Files (and other files as appropriate) for completeness and to rectify any deficiencies prior to archive
  • checks that original consent forms have been completed and filed appropriately
  • checks that medical records are flagged appropriately
  • checks that all samples collected during the study have been stored appropriately (so as not to compromise the integrity of the samples) and shipped to the appropriate destination for analysis

 

[1] A participating site may need to be closed whilst the study is on-going (i.e the study has not declared ended).  This may be at the request of the sponsor/REC/MHRA, the participating site or due to force majeure (an unavoidable event).  Through discussion Noclor and the Chief Investigator will ensure the appropriate action is taken and documented in the Study Trial Master File (S/TMF) commensurate to the circumstances of the site closure.

[1] Any change to the definition of the end of study should be notified to the Noclor Sponsor Representative (where a Noclor partner is the sponsor) as this may require a substantial amendment being submitted to the Research Ethics Committee (REC) and the MHRA (for CTIMPs).