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ColoCap Study

1Trial Management Group (TMG)

We have a Trial Management Group (TMG) which is responsible for reviewing the ongoing progress and conduct of the trial including:

  • Progress of study and site opening
  • Recruitment rate (actual versus predicted)
  • Site issues
  • Data quality and return rate
  • Protocol amendments
  • General research study issues

Our TMG is made up of the research team and includes our public co-applicant.

2Patient Advisory Group (PAG)

We have established a Patient Advisory Group (PAG) which is made up of 9 individuals who have had, or have been carers of those with, bowel disease or who have had bowel investigations. 

The PAG will help develop all patient facing materials, including co-producing the patient interview topic guides, patient information sheets and the patient questionnaires in WS3. The PAG will be involved in identifying patient-centred themes from interviews in WS3. 

The PAG will also provide a patient perspective on the write-up of papers, help produce lay summaries, and assist in presenting the study findings results at conferences, support groups, charity events and online. They will be integral to the dissemination and implementation phase of the programme.

 

3Trial Steering Committee (TSC)

Our Trial Steering Committee has overall oversight of the  research study and provides advice to the trial management group (TMG), funder and sponsor of the research.

This includes:

  • Monitoring the progress of the trial
  • Monitoring adherence to the protocol
  • Considering recommendations from the Data Monitoring Committee (DMC)
  • Making recommendations to the Trial Management Group (TMG).
  • Making recommendations to the trial Sponsor
  • Considering new information as it becomes available.

This is made up of a mixture of independent members and members of the research team. There is a public member on the TSC. 

4Independent Data Monitoring Committee (IDMC)

The Independent Data Monitoring Committee (IDMC) monitor patient safety and efficacy data while the study is ongoing.

Our IDMC is made up of  3- 4 members who are experts in their field. They are completely independent of the research team.

1st April 2023 – 31st March 2024

York & Scarborough

50 research studies open to recruitment

=

3246 patients recruited into clinical trials