Running and closing a study
Amending or changing a study
Any change to a study or study document is an amendment. The nature of that change determines how is it handled and approved. The sponsor of a study will determine whether they are ‘substantial’ or ‘minor’ amendments.
All Barts Health and Queen Mary sponsored studies follow a standard process (SOPs). Our SOPs cover all aspects of setting up, running and closing down clinical trials, plus training, monitoring and audit.
All amendments should be submitted to Research.amendments@qmul.ac.uk.
Full details of the amendment process can be found on the HRA website.
Reporting incidents
The Barts Health or Queen Mary reporting procedures should be followed whenever an incident occurs. When reporting an incident in the Barts Health DATIX system you must ensure that it is identified as a research-related incident.
If an adverse event occurs during a trial that is sponsored by BH or QMUL the PI should assess if it is an SAE. The SAE reporting form, an associated document to SOP 37 should be sent to bartshealth.research.safety@nhs.net
Reports of SAEs or Suspected Unexpected Serious Adverse Reactions (SUSARs). by fax will not be accepted as due notification unless email systems are down and prior contact has been made with a member of the GCP team.
The JRMO does not require externally sponsored research to report SAE or SUSARs events to them. For Non-CTIMPs, only events which are both related and unexpected should be reported to the JRMO. The appropriate JRMO template should be used. The CI should record all other events in a case report form on the HRA website.
Full information about the notification of incidents can be found on the HRA website
Closing a study
For all research studies except CTIMPs, it is the responsibility of the CI to notify the REC of the end of a project. This must be done within 90 days of the end of the study and should be carried out in accordance with guidance on the HRA website, which includes forms to use.
The HRA guidance defines ‘end of study’ and covers declaring an end of the study, the final report, informing participants, publishing results, post-research care and other end-of-study considerations.
A copy of the final report must also be sent to the JMRO - refer to SOP 18a for full details.
If the Sponsor decides not to start a study or does not recommence the study after halting it, they should notify the MHRA (or relevant Competent Authority) and include a cover letter identifying the protocol, its protocol code number and EudraCT number, providing a brief explanation of the reasons for not starting the study or not starting it again.
Whenever a study is terminated early the sponsor must notify the MHRA (or relevant competent authority) within 15 days and clearly explain the reasons for termination.
Archiving
During the course of the study, all records are the responsibility of the PI and must be kept in secure conditions.
Records should be sent for storage as soon as possible after the study is fully completed, and where the records are no longer needed for reference and kept for a further 25 years. See JRMO Archiving SOP 14 and SOP 20 or contact the JRMO team for further information.
At the end of the 25-year period, the records management team will alert the JRMO that the records are due for disposal. The CI and Sponsor will be informed and the records will be destroyed only with the full agreement of everyone concerned. Records can be requested from the Records Centre at any time during this period by giving full details of the required files.
For further advice, please get in touch with Barts Health Records Management: records.management@nhs.net
All records relating to the study should be stored together where possible, including:
- The Study master file
- The Investigator Site file
- All the PI’s documentation
- Patient Case Report Forms (CRF)
- Any related files held by the Pharmacy
For a site-only study, the PI should ensure a full set of records is collated and documented (including any pharmacy files), otherwise, it is the responsibility of the CI.
Arkivum
In 2023 Barts Health Corporate Records service procured a digital archive system that is suitable for the long-term storage of research records. Arkivum provides a fully managed archiving and preservation solution compliant with:
- ISPE GAMP® 5: Compliant GxP Computerized Systems
- FDA 21 CFR Part 11, 210, 211, 820
- EU Commission: EudraLex Volume 4 GMP Annex 11
- ICH (International Council for Harmonisation) E6, E9, Q7A, Q9, Q10
- MHRA GxP Data – Guidance for Industry
- ISO 9001:2015 – International standard for a quality management system (QMS)
- ISO 27001:2017 – Information security management
Records from all clinical research studies sponsored by and/or hosted within Barts Health and QMUL can be stored. Almost all file formats can be ingested, archived, and safeguarded. There is no size limit, and it is designed to hold patient-identifiable data. There will be a cost associated with this service for new studies and the fees will be available as soon as they have been confirmed. For further information see the Arkivum FAQs (August 2023|) [PDF 82KB]
Please contact records.management@nhs.net if you have records for closed studies you’d like to transfer, or if you have additional questions.
