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After Gaining NHS Permission

Once your project has gained NHS Permission, whether the study is being led from DHFT or elsewhere, Our team will help you start and run the study for the whole of its life-cycle. Advice and support of available for:

Site Initiation Visits (SIV)

The SIV, arranged by the Sponsor and undertaken prior to participant recruitment, is designed to prepare a site to run the study.  For most types of study an SIV is crucial. All relevant study personnel at a site will be invited to attend as this meeting. This meeting offers the opportunity to discuss:

  1. protocol  
  2. inclusion/exclusion criteria  
  3. study procedures and documentation (IT systems)  
  4. the research participant pathway  
  5. Monitoring plan  
  6. Study specific requirements such as support services 
  7. Study specific training  

 

Investigator Site File (ISF)  set-up

 The ISF consists of essential documents related to the study and specific documentation relating to the site.  It is essential for all studies to have an ISF in order to run the study to ICH GCP standards.  This file should be kept at the investigator site.

  1. For DHFT Sponsored studies the Trial Manager will help set up the ISF.
  2. For commercially sponsored studies the company normally provide the ISF. For studies conducted on behalf of smaller companies or for investigator-initiated studies, the study team prepare the ISF, structured in accordance with a defined template.

 

Reporting Recruitment locally to DHFT R&D or to study Sponsors

 It is essential that patient recruitment for your study is reported according to Sponsor requirements. The DHFT R&D Department will help you to ensure accurate and timely reporting of recruitment to your study.

Safety reporting to sponsors and regulatory bodies

 Depending on the type of study you are running then you may need to report on safety aspect to regulatory bodies. If you are running a CTIMP or device study then all adverse events relating to the trial will need to be reported to the Sponsor, MHRA and Ethics Committee.  Seek advice from the R&D Department for project specific processes.

Submitting progress reports

 You may need to submit a report(s) during your study depending on study type.

Annual Progress Report

Sponsors and Funders may request a report during you study.  Requirements will be Sponsor and study specific. The REC will require an annual report and an end of study report.

Making project amendments

 You may wish to make changes/amendments to your project. Depending on the nature of the amendment the R&D Department will advise you on the process.  All study amendments require review and approval by the  R&D Department. Amendments include changes to the:

  1. Protocol – the way the study is conducted
  2. Study team – changes in personnel
  3. Funding – changes in amounts or administration

 Guidance on the categorisation of amendment can be found on the HRA website.

Trouble shooting problems encountered during your research study

 The R&D Department can work with you to help resolve any issues you encounter during your study, such as:

  1. Logistical problems encountered when running your study
  2. Problems with recruitment to the study
  3. Issues with staffing the project
  4. Training requirements

 

Trial Monitoring

Our experienced Clinical Trials Managers can provide expert monitoring services to ensure your study is running safely with respect to participants, and  in accordance with the protocol, ICH GCP and all applicable regulatory requirements. The level of monitoring required will be dependent on the risk associated with your project, and can be discussed and planned for prior to the study commencing.

  1. In-house monitoring of DHFT are the Sponsors
  2. Facilitating external monitoring by Sponsors or regulatory bodies


End of study notification and report to Sponsors and regulatory bodies

When a study has ended then you must notify the relevant stakeholders and regulatory bodies:

  1. Notify the study Sponsor.
  2. Notify the REC within 90 days of the end of the study:  See the HRA website.
  3. Notify the MHRA (for CTIMP and device studies) within 90 days of the end of the study. Click here to go to MHRA website.
  4. Notify the funder if required.

 

Close Out Visits

 When the study has ended (subjects are no longer taking part in the study, all data have been collected, all outstanding Queries/data clarifications have been resolved) then then a ‘close-out visit’ is conducted by the Sponsor.  The Close-out visit will ensure that all study activities have ended at site and the documentation can be archived. If DHFT are the Sponsors of your study then the R&D Department will work with you to close your study, and any other participating sites.  If your study is not being sponsored by DHFT then please inform the R&D Department of any close-out visits.

Final Study Report

 A final research report is required to be submitted as well to the REC and MHRA (for CTIMP or device studies) within 12 months of the end of the study.    

Archiving

At the end of a study all research related documentation must be archived adequately.  The R&D Department will advise you on the archiving requirements of your study. The Sponsor of your study will provide information on when and how to archive your documents.  It is important to ensure that the arrangements are defined at the start of the study to ensure adequate facilities and funding. A quick guide to archiving periods: 

    • Non-CTIMP and non-device studies archived for 5years or CTIMP and device studies archived for 15 years   
    • Paediatric study documents archived until the participant reaches their 25th birthday, and 26th birthday if recruited at 17 years of age.