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Staff role definitions

We want to ensure researchers get the best possible support from the Pragmatic Clinical Trials Unit and know who is responsible for which tasks within the unit. Different clinical trials units operate differently so this guide applies specifically to the Pragmatic Clinical Trials Unit. 

Please see below outlines of some of the roles individuals can play within a trial. You may wish to refer to this guide in combination with the support services available when requesting PCTU support. Staff listed below are employed by the PCTU. Funding for their roles is incorporated in research grant applications, and for successful grants this funding is then paid by the organisation that receives the grant direct to the PCTU to pay these staff.

Data Manager

We offer database design appropriate to the individual needs of each project we support. The data manager will develop appropriate data management strategies for trials and advise on their implementation. They will advise on current regulatory framework regarding data protection and data management procedures in compliance with data protection act and other regulations.
The data manager will advise on suitable database for individual study and set up databases in liaison with chief investigators, statisticians and health economists working on trials. Each database will have integrated data validation checks and full audit trails. Clinical and patient identifiable data are kept on physically separate databases. The data manager will advise on and set up data transfer systems and encryption systems so that all patient identifiable data is encrypted. The data manager will also advise on storage, back-up and archiving of data to ensure databases are regularly backed up to ensure data are safeguarded from accidental loss. In addition to this data management covers the following tasks:

  • Advise on case report form (CRF) design
  • Agree with chief investigator time line for database set up and database lock
  • With chief investigator, draw up trial data management standard operating procedures (SOPs).

Health Economist

In some clinical trials, it can be important to compare how much different treatments cost, as well as how well they work. This can be particularly important when two (or more) treatments are equally effective, but differ considerably in their costs. An economic evaluation as offered by our health economist will ensure that all costs (treatment, care and recovery, as well as the costs of prevention, research and training of healthcare personnel) have been considered when the trial results are presented. 
The health economist will:

  • Develop plans for economic analyses and advise on appropriate data collection
  • Collaborate with statisticians and data managers working on trials to ensure appropriate data management systems
  • Carry out economic analyses for trials including modelling
  • Input into report and publication papers.

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Quality Assurance Officer

The quality assurance officer will train trial staff in PCTU SOPs as relevant to their work, and review and advise on content of study specific SOPs. They will also liaise with chief investigators and agree risk assessment and subsequent monitoring plan for their study and conduct audits as required, They will also ensure on-going study compliance with Good Clinical Practice (GCP), the clinical trial regulations and sponsor requirements and advise on staff GCP requirements, clinical trial regulatory requirements, adverse event reporting and on PCTU support available.

PCTU Manager

The PCTU manager will act on behalf of the unit director and negotiate with chief investigators over PCTU involvement in trial, agreeing costs and timing. The manager will liaise with the Joint Research Office over costings for PCTU staff and with grant holding organisation regarding transfer of funds for PCTU support. They manage the PCTU budget and also liaise with R&D departments to ensure necessary contracts are in place.

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PCTU Administrator

The administrator acts as first point of contact for researchers wishing to collaborate with the PCTU. Day to day admin within the unit covers tasks such as:

  • Filter enquiries to the unit, liaising with unit staff as necessary
  • Maintain records of all agreements between CIs and PCTU
  • Maintain database logging PCTU activity
  • Maintain database of active and completed projects supported

Administrative support for supported projects includes design and maintenance of trial websites for all supported projects.
Further administrative support can be arranged (mainly for trials lead from within the Centre for Health Sciences) to include for example trial correspondence, liaising with research staff or setting up site files as required.

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Statistician

Statistical support is required at all stages of a project starting with input into protocol development. Further support includes developing analysis plans, performing randomisation or minimisation for trials, liaising with health economist and data managers working on trials, or other studies under the remit of the PCTU, to ensure appropriate data management systems are in place and of course carrying out statistical analyses. Other tasks performed by the statisticians are:

  • Carry out sample size/power calculations
  • Input into CRF/data capture tools development
  • Write detailed statistical analysis plans
  • Liaise with data manager to ensure adequate cleaning of final dataset
  • Write and check Stata.do files or other appropriate programmes to perform data manipulation and analysis
  • Produce reports for the Data Monitoring Committee, Trial Steering Committee or funder as necessary
  • Perform any pre-planned interim analysis blinded to treatment allocation. If unblinded analysis is necessary, such analysis will be performed by another statistician in the PCTU.
  • Attend trial/study team meetings where possible
  • Liaise with data manager and trial manager throughout the duration of the trial to ensure data quality and integrity
  • Write a final statistical report
  • Authorship on publications arising from projects
  • Respond to publication reviewers’ comments.

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Trial coordinator / Trial manager

The trial coordinator or manager will maintain general oversight of trial coordinating participating sites as necessary over the full duration of the project. They also manage the trial administration by ensuring that files and documentation is up to date and complete, by keeping accurate written and computerised secure and safe records. They will ensure that all clinical trials procedures are fully compliant with the PCTU’s and sponsor’s standard operating procedures as applicable to the trial.
They will act as the point of contact for all external and internal agencies and provide efficient day-to-day management of the trial.
This includes but is not limited to:

  • Maintain confidentiality and security of patient and staff records
  • Recruitment, retention, training, appraisal and supervision of trial team members.
  • Establish procedures to ensure adherence to trial protocols and administrative requirements
  • Ensure the timely recruitment of trial participants with secure randomisation processes and subsequent efficient and effective data management
  • Monitor the trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems
  • Manage the trial budget(s) and maintain the accounts
  • Coordinate the preparation and publication of data, reports and information, ensuring that these meet legislative, contractual and ethical requirements
  • Liaise with the Trials Steering Committee and Data Monitoring and Ethics Committee with a particular view on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements
  • Provide regular and ad hoc information, both written and verbal, to all the trial participants, funders and sponsors. This could include reports, updates, guidance, proformed commitments and, possibly, a Newsletter.
  • Work with the Chief Investigator to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time
  • Ensure the inclusion of patient representatives at the appropriate levels and times
  • Plan and support meetings and work of the various groups and bodies associated with the trial.

The trial coordinator will also have access to additional advice and assistance from the PCTU’s senior trial manager as well as the quality assurance officer. This will be particularly relevant at approval stage, when liaising with various external agencies to gain the appropriate approvals for the project, and in the event of any non-compliance or serious adverse events.

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Trial monitor

PCTU will monitor and/or audit PCTU supported CTIMP and non-CTIMP trials on a risk-based basis as agreed by the sponsor. The monitoring plan will be agreed by the CI, sponsor and PCTU QA manager prior to study initiation.
Tasks performed by the monitor are:

  • Source data verification
  • Monitor progress of trial
  • Confirm that all adverse events are being documented and reported as necessary
  • Check CI adheres to their responsibilities according to GCP and delegates responsibilities appropriately
  • Scrutinize trial related documents
  • Examine research staff on their knowledge of the protocol
  • Ensure that the trial is being conducted according to GCP, clinical trial regulations and sponsor requirements.

The purpose is to verify that reported trial data is correct, complete and verifiable (ICH GCP 1.38 and 5.18.1). Findings are reported to the PCTU QA manager and sponsor via a monitoring report.

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Trial Specific Staff

In addition to this trials will require members of staff that have a more substantial role in individual trials. At the moment the PCTU does not have the capacity to offer any of the following as a core service  and so these staff are recruited directly by trial chief investigators and paid directly from research grants.

The links below will take you to sample task lists for these roles. Chief investigators may find these useful when drawing up job descriptions and recruiting.