Contributions made by PRIMENT CTU to research begin at the pre-design phase and are carried forward to full completion of the study. These are detailed below:
1) Development of outline/full application – This includes working with clinicians/ psychologists/sociologists/pharmacists/other relevant professionals to develop the most appropriate study design. Once a decision has been made to take the study forward, a further detailed discussion occurs with the principal investigator. This will in the case of a clinical trial, involve clarification of the study population, study design, details of the intervention and the comparator, outcomes of interest, analysis plan and write up of relevant sections of the grant application.
2) Following award of the grant – further input is required, such as revisiting the study protocol and the analysis plan, finalizing the randomisation procedures, operationalising the research, developing appropriate data collection forms and both treatments and research specific study manuals, contributing to the ethics submission, attending the study launch meeting and assisting with the Clinical Trial application(CTA) if necessary.
3) Recruitment phase – maintaining an overview on randomization, recruitment and the development of trial reports for the Data Monitoring (DMC) and trial steering committees (TSC).
4) Follow up phase – includes a close overview of follow up rates, running appropriate data checks, further preparation of reports for the DMC and TSC.
5) Analysis and publication – overview and supervision of the data cleaning and the analyses, contribution to the preparation of the final trial report and publications.
6) Continued responsibilities for data management and further interactions with DMC and TSC and ongoing contribution to final publication.
In addition to these tasks there are other generic skills provided by our CTU on project management such as financial planning, quality assurance, quality control, IT support and administrative support. This input starts at the pre-design phase and carries on until the study is completed. PRIMENT will engage with the applicant on costing each study at the time of making an application. After the study is funded, we offer guidance on: applications to local NHS R&D committees; IT related issues such as developing study specific databases and tailored operational management assistance specific to the study
Please click here to download a PRIMENT support request application and email your request to npk@gprf.mrc.ac.uk.
