Recruitment
Reporting recruitment data relates to the number of participants consented into any research project. This information is recorded for two separate reasons:
For safety monitoring purposes it is necessary for Cardiff and Vale University Health Board (CAVUHB) to be aware of how many patients are taking part in different types of projects.
Accurate recruitment data is required to ensure sufficient income can be obtained from Health and Care Research Wales to support the delivery of these studies at Cardiff and Vale UHB.
Recruitment data for all projects should be uploaded to the Local Portfolio Management System (LPMS) locally called ReDA, on a weekly basis as a minimum.
If you have yet to receive training or gain access to LPMS/ReDA, please contact Cardiff and Vale UHB R&D Office.
Substantial Amendments
Substantial amendments involve significant changes to the design and methodology of a research project. A substantial amendment is defined as an amendment to the terms of the application, or to the protocol or any other supporting documentation, that is likely to affect to a significant degree:
- the safety or physical or mental integrity of the subjects of the study;
- the scientific value of the study;
- the conduct or management of the study; or
- the quality or safety of any investigational medicinal product used in the trial.
They should be submitted to the relevant review bodies for approval before the changes can be implemented unless there is an urgent safety issue.
Some examples of substantial amendments can be found here: Examples of substantial and non-substantial amendments – Health Research Authority (hra.nhs.uk)
Amendments
Amendments are any changes made to a research project after the favourable ethical opinion and/or Health Research Authority (HRA)/Health and Care Research Wales (HCRW) approval has been issued. Amendments are classified as either substantial or non-substantial, depending on the nature of the change. Where amendments are submitted to the review body, they will be further categorised depending on which research sites are affected by the change.
All amendments to a study should be reviewed, agreed and authorised by the study Sponsor. It is the responsibility of the Sponsor to classify the amendment. For Cardiff JRO sponsored studies, the study Sponsor will be either Cardiff University (CU), or Cardiff and Vale University Health Board (CAVUHB).
Amendments must not be submitted without prior authorisation from the Sponsor.
It is the responsibility of the Chief Investigator (CI), or an appropriately delegated member of the research team, to notify the Sponsor of any amendments to a research project and draft the associated amendment documentation. When preparing an amendment for submission, an amendment tool and any accompanying study documentation should be sent to the study Sponsor for review. The most up to date version of the tool can be found here: IRAS Help – Maintaining your approvals – Amendments (myresearchproject.org.uk). If completed correctly, the amendment tool will automatically classify and categorise the amendment for you.
Once an amendment has been authorised by the study Sponsor, it is the responsibility of the CI, or an appropriately delegated member of the research team, to submit the amendment via the IRAS Identity Gateway website, and notify any supporting sites (NHS or non-NHS) of the submission.