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Study Activation

There are a number of steps that must be completed before a research study that is sponsored by a Noclor partner can commence (or re-start after a temporary halt). For clinical trials, the process of study activation is a formal one whereby the sites will be issued a study activation notice from Noclor.  No study procedures should be undertaken before the activation notice is received.

The key steps are summarised below.  Please use the left control image and right control image to navigate through the steps and refer back to the relevant sections for more details as required.

    • The research idea is defined as research within the scope of the Research Governance Framework for Health & Social Care
    • The protocol has a well-focused research question
    • The research is novel and feasible
    • Colleagues, collaborators, service users, RDS and CTU as appropriate have been involved in the design and development of the protocol
    • Risks against foreseeable benefits to the research subjects or to others have been carefully considered
    • The protocol has been independently peer reviewed
  • Sponsorship

    • Valid sponsorship request submitted
    • Evidence of peer review
    • Risk assessment completed
    • Responsibilities delegated to Chief Investigator
    • Sponsor declaration

    Funding

    • Contact with Noclor finance team
    • Collaborators and third parties identified
    • Costings completed
    • Authorised signatories evident
    • Application submitted
    • Funding confirmation received
    • Prime contract signed
  • Study & Submission Documents

    • Finalised protocol
    • PIS, consent forms, GP letter
    • Authorised IRAS form
    • Other supporting documents & cover letters (as required)

    Additional requirements for CTIMPs:

    • Sponsor authorised protocol
    • Additional documents for Clinical Trial Authorisation (CTA) application

    Registrations & Approvals

    • Registrations (as required)
    • REC favourable opinion (as required)
    • Host site approvals
    • Other permissions (as required)

    Additional requirements for CTIMPs:

    • Clinical Trial Authorisation (CTA)
  • Study Set-up Complete

    • Contracts & Agreements initiated and executed
    • Data capture tools finalised
    • Trial supplies sent to sites
    • Study specific training documented
    • Study/Trial Master File established
    • Study manual/SOPs finalised

    Additional requirements for CTIMPs:

    • Site initiation reported (reviewed by sponsor)
    • IMP supplies ordered
    • Sponsor authorised regulatory release of IMP to sites

    Final Checks & Notifications

    The Chief Investigator should ensure that the research study/research sites meet the following study activation requirements prior to the study commencing at site (and prior to a site activation notice being issued by Noclor (for clinical trial sites)).

    Checklist for All Research

    Activation Checklist Item Type of Evidence
    Contracts & agreements executed Signed contracts on file
    CI Delegation of Responsibilities Agreement (for Clinical Trials) Agreement signed by both parties (CI and sponsor). For non-clinical trials, the IRAS CI Declaration will suffice (unless otherwise specified by Noclor).
    Favourable Ethics (where required) Letter (and conditions met)
    Monitor plan (for Clinical Trials) Signed document (CI and sponsor)
    Sponsorship declaration Signed letter
    Host Permission (NHS or non-NHS) Letter (or email)
    Noclor SOPs (where relevant) Signed by CI

    Additional requirements for CTIMPs:

    Activation Checklist Item Type of Evidence
    Clinical Trial Authorisation (CTA) Letter of acceptance (MHRA)
    QP certification Release certificate from QP (as per technical agreement)
    Authorised release of IMP /confirmation of receipt at site Email trail (evident in TMF).
    Approved protocol signed All relevant parties - CI, sponsor representative and PI’s (PI’s to sign protocol version acknowledgement signature page)
    Site initiation completed and reported Initiation report reviewed by sponsor (with no outstanding actions)
  • Once all study activation requirements have been met the study can commence.

    For clinical trials, a site-specific study activation notice will be issued by Noclor. Upon receipt of this notice the site may commence the study. NO study procedures should be undertaken before the activation notice is received. A copy of the activation notice should be filed in the Trial Master File (TMF) and in the Investigator Site File (ISF) at the relevant site.

    The study will now be defined as ‘ACTIVE’ and should be conducted according to the protocol, Noclor procedures, GCP and the relevant regulations until the end of study declaration.

    Any changes to the study post-activation should be notified to the Noclor Sponsor Representative and relevant bodies as appropriate (refer to specific guidance).