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Table 2 Trial organisation and management

From: Protocol of a two arm randomised, multi-centre, 12-month controlled trial: evaluating the impact of a Cognitive Behavioural Therapy (CBT)-based intervention Supporting UPtake and Adherence to antiretrovirals (SUPA) in adults with HIV

Group

Contact details

Sponsor

Trial Sponsor: Brighton and Sussex University Hospitals NHS Trust; Sponsor’s Reference 13/117/HOR; Contact name Scott Harfield; Address: Research & Development Directorate, Royal Sussex County Hospital, Eastern Road, Brighton, BN2 5BE

Telephone: 01273 696,955 ext. 3538

E-mail: sponsorship.approvals@bsuh.nhs.uk

 

Main role

Specific responsibilities

Trial Management Group (TMG)

(Chief investigator, Programme Managers)

Responsible for the design and conduct of SUPA and day to day management of the trial

-study planning

-organisation of committee meetings-Provide annual report to funder

-provide accrual figures to each site-Budget administration and contractual issues with individual centres-Advice for lead site investigators-Ethics committee and R&D applications-Data verification-Randomisation-Organisation of data storage

-preparation of protocol and revisions to trial documents,

-managing publication of study reports

-maintaining databases, randomising patients,

-ensuring complete and correct data

-preparing reports

-dealing with research governance

Programme Management Group (PMG)

Assisting in managing the trial, including the clinical and practical aspects

-input into and comment on the protocol and all trial documents

-develop strategies to address any issues with recruitment

-provide clinical or other expert guidance on clinical and practical queries and interpretation of information recorded on CRFs

-input into the meetings of the PSC and IDMC when appropriate (open sections only)

-provide responses for and consider the implications of any recommendations made by the IDMC and accepted by the PSC

Programme Steering Committee (PSC)

To act as the oversight body for this trial on behalf of the Sponsor/Funder

-provide expert oversight of the programme

-make decisions as to the future continuation (or otherwise) of the programme

-receive letters of feedback from the IDMC and consider their recommendations

-assess the impact and relevance of any accumulating external evidence

-monitor recruitment and follow-up rates and review strategies from PMG to deal with problems

-approve any amendments to the protocol, where appropriate

-approve any proposals by the PMG concerning any change to the design of the programme, including additional substudies

-approve / comment on the statistical analysis plan, publication policy, main programme manuscript

-approve external or early internal requests for release of data

Independent Data Monitoring Committee (IDMC)

Safeguard the interests of participants, assess the safety and efficacy of the interventions during the trial, and monitor the overall conduct of the trial. It is independent from the Sponsor.

-receive and review information on the progress and accruing data of this programme and provide advice on the conduct of the programme to the Programme Steering Committee (PSC)

-inform the Chair of the PSC if, in their view the results are likely to convince a broad range of clinicians, including those supporting the programme and the general clinical community, that, on balance, one trial arm is clearly indicated

-perform interim review of the programme’s progress including updated figures on recruitment, data quality, adherence to protocol treatment and follow-up, and main outcomes and safety data

-monitor: evidence for treatment differences in the main efficacy outcome measures, evidence for treatment harm, recruitment figures and losses to follow-up, compliance with the protocol, sample size assumptions, compliance with previous IDMC recommendations, data quality and completeness

-assess the impact and relevance of external evidence

-suggest additional data analyses if necessary

-advise on protocol modifications proposed by investigators

Lead Site Investigators

Responsible for local site trial management

In each participating centre a lead investigator (HIV consultant) will be identified, to be responsible for identification of patients, recruitment, data collection and completion of CRFs, along with follow up of study patients and adherence to study protocol at their local site.