During and after your study

As your study progresses the study team is responsible for:

During

You can now start recruiting participants. Alongside your recruitment and study activity you must ensure that the following are carried out:

• Ensuring the study is carried out in accordance with the protocol and the latest approved documents are used. In addition, clinical trials must be carried out in accordance with the Declaration of Helsinki.

• Ensuring records and documents are up to date and the relevant bodies informed. If there are any changes to the study these must be submitted to the HRA for approval. First the sponsor must categorise the amendment as substantial or non-substantial. Substantial amendments need to be approved by the REC if the study type requires REC review. Non-substantial amendments should be submitted to the HRA (hra.amendments@nhs.net). Amendments then need to be agreed by all applicable sites. Sites have 35 days to respond and if they do not respond within that time, the amendment may be implemented at that site. There are templates for amendment notifications which can be found on the IRAS site. You may also need to notify other bodies, such as MHRA, if these were involved in the original approval. All applicable NHS R&D offices also need to be informed of any amendments. For further information please click here.

• Communicating with research sites. Sites should be kept updated and have a point of contact in the study team for any queries.

• Ensuring site files are up to date. Sites must each hold a paper site file which includes a full and up to date set of documents including the delegation log; training log; CVs of all involved staff at the site; all current versions of study documents; documentation about regulatory approvals; study protocol; information about procedures taking place at the site and correspondence.

• Ensuring staff have the relevant training. This means the training, education and/or experience to allow involved staff to conduct the research. So for example if a member of the team is taking blood samples they must be trained to do so. This training may include Good Clinical Practice training – your HRA approval letter should confirm whether this is required. All staff involved in research may find this training useful.

• Reporting serious adverse events. There should be a procedure in place for reporting these which needs to be communicated to each site, and all events must be responded to appropriately and reported to the relevant bodies.

• Documenting consent forms. Consent forms should be kept in a safe place and data protection complied with.

• Ensuring data and samples handled appropriately. Consider who has access, where any paper records are kept, who is given smart card access to NHS systems, how samples are transported and by whom.

• Ensuring current Letters of Access for any study staff accessing NHS premises. Any staff member who will be accessing an NHS site for research purposes should have a letter of access (for details see here), and these should be current to reflect required access. To apply for a letter of access please contact research@bradford.nhs.uk.

• Updating recruitment onto CRN database. Number of study recruits should be updated monthly onto the Central Portfolio Management System (CPMS) for portfolio studies. Please see here for further information.

• Annual progress reports. The requirement for annual reports has recently been changed by the HRA. Please see here for detail of safety reporting.

After

After completion of a study consideration should be given to:

• Patients and their experience of the study. Please see here for details.

• End of study reports should be submitted to the REC within 90 days of the end of the study and copies sent to NHS R&D. If the study was not REC approved the end of study report should be sent to the HRA with your IRAS ID and contact details. If the study was a CTIMP the end of study form should be sent to MHRA within 90 days of the end of the study. See here for templates. If your study was with the Confidentiality Advisory Group the Confidentiality Advice Team should be notified of the end of the study in writing to hra.cag@nhs.net.

• The final research report should be sent to REC and MHRA (for CTIMPs) within 12 months of the end of the study.

• Study outputs should be shared with participants and research sites if possible. We can also share these on our site so please send these to research@bradford.nhs.uk.

• Study site files and documents should be kept as documented in the original application, and sites should be communicated with to let them know how long they need to keep information for and how.

• Dissemination events can be useful for getting your message out to the community. We can help you to promote any events, so please contact research@bradford.nhs.uk for advice.