Submission to Trial Start

Please note that the CTRG pages are currently under development.
If you have any questions please contact elaine.chick@admin.ox.ac.uk

 

Protocol registration

Journals which follow the Guidelines released by the International Committee of Medical Journal Editors (ICMJE) require many studies to have been listed on an independent, free to access, validated, public register.

This includes:

  • Trials whose primary purpose is to affect clinical practice
  • Trials providing evidence of clinical effectiveness or adverse effects
  • Investigations of the biology of disease
  • Collection of preliminary data who may lead to larger clinical trials
  • Device trials

The study must be registered before the first patient is recruited. Authors whose trial is unregistered will have to convince the editor that they had a sound rationale when they decided not to register their trial.

Acceptable registries include:

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Agreements

Regardless of whether or not your study has commercial involvement, contracts and agreements will need to be in place prior to the start of your study if any third party (including facilities or services from an NHS Trust or other university) is involved. These include:

  • Supply of the Investigational Medical Product
  • Funding/Educational grant
  • Laboratory services
  • Pharmacy services
  • Out-of-hours code breaking services
  • Emergency medical cover
  • Participation of other sites (in multicentre studies)

CTRG can help you to identify what agreements are required for the study. Medical Research Services will help put these in place.

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Delegation of Sponsorship Responsibilities

Whilst the University, as Sponsor, is legally responsible for the overall conduct of your trial, the Regulations allow for these responsibilities to be shared or delegated by written agreement. Prior to your study start, CTRG will need to agree with you which responsibilities it is appropriate to delegate to the Chief Investigator or other individuals or organisations. Delegation of specific responsibilities depends on the resources that are available for your particular trial and the level of experience and related training acquired. The range of possible delegation of roles is outlined in the Delegation of Sponsor Responsibilities.

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Delegation of Authority

The day-to-day running of your trial will inevitably involve other staff to whom authority is delegated by the Chief/Principal Investigator via a written legal agreement that must  be filed within the SOP Template for Trial Master Files (122kb). Please also see our Trial Master File Index (86kb) .

Staff accepting these responsibilities must sign the delegation log. A Log of Delegation of Responsibilities and Signatures (35kb) is available for this purpose.

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Trial Master File

The Regulations require a Trial Master File (TMF) to be kept for a clinical trial. It should be set up as soon as there are documents requiring filing. We recommend they are filed together, in a coherent format to enable ease of access and so they are readily available for GCP monitoring, audits or inspections. Guidelines for Good Clinical Practice (GCP) (380kb) (Section 8)  has particular requirements for the contents of a TMF. To aid compliance the following templates are available which can be adapted as required:

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Standard Operating Procedures

The Regulations require you to have Standard Operating Procedures (SOPs) in place prior to the start of the study. These should cover the range of activities involved in the study conduct and are designed to ensure that practice is standard, regardless of who is carrying out the activity. Staff involved in the study should have been trained in the activities for which they are responsible and a clear concise SOP will guide anyone unused to that particular procedure.

CTRG has a range of template SOPs, including an SOP Template (49kb), which can be adapted by individual investigators or departments. CTRG staff will be able to identify which SOPs are required for your study.


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Data Management and Case Report Form design

The design of a clear Case Report Form (CRF) and the system for recording and storing data electronically are essential aids to GCP compliance and early consideration should be given to this. The following templates are available:

Whilst many researchers have access to software specially designed for the construction of databases, this is not essential for producing a compliant database.

A database should

  • have a written specification (what it is intended  to do) – to be filed in the TMF
  • be secure but accessible by those authorised to do so
  • have a clear audit trail (what data additions and amendments have been made, when and by whom)
  • be validated (tested) as 'fit for purpose'

If you need help or advice with the construction of your spreadsheet, please contact CTRG staff.

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Training

The Regulations require that each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task. This applies to the Chief/Principal investigator, and to any staff to whom responsibilities are delegated. The Chief Investigator is responsible for making sure all staff are appropriately trained for their role.

Training would include relevant SOPs and GCP training. At least one member of a study team must have received detailed training on safety reporting. All training should be recorded and the records must be accessible for monitoring, inspection and auditing. An SOP Template for Qualification, Experience & Training of Clin. Res. Personnel (51kb)  is available.

CTRG organise GCP training days on a regular basis. Contact the CTRG administrator for bookings and details.

An online GCP course is available free to employees of the University or the Oxford University Hospitals NHS Trust, or anyone working on a study sponsored or hosted by either  organisation. There are five modules:

  • Protocol and Associated Document
  • Applications, Agreements and Approval
  • Trial Master Files
  • Conducting the Trial
  • Safety Reporting

Register via https://secure.admin.ox.ac.uk/rso/gcp/.

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