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Changes to Sponsor

During the active1 phase of a research study circumstances may arise that mean changes to the sponsor declaration or sponsor contact details have to be made.  Depending on the circumstances, the proposed change and the study type various actions will need to be taken by the sponsor or Chief Investigator (as delegated).   

The table below provides some examples of what changes to sponsor may occur and what action should be taken by the relevant party.

CHANGE TO SPONSOR

REQUIREMENTS Additional requirements for CTIMPs
Change of sponsor contact or contact details 

Requires notification to the main REC (that provided initial favourable ethical opinion) by Chief Investigator.

Refer to sponsored research amendment process.

Requires notification to MHRA by (sponsor) person named on C1 of CTA application.

Refer to MHRA guidance.

Change of sponsor name (where legal entity remains the same)

Requires substantial amendment to be submitted to the REC (that provided initial favourable ethical opinion) by the Chief Investigator.

Refer to sponsored research amendment process.

Requires a substantial amendment to be submitted to MHRA by the sponsor (or authorised sponsor contact).

Changing the name of the sponsor results in a new CTA number being issued for the trial. It is therefore important that the change of sponsor name is the only (substantial) amendment made at that time.

Refer to MHRA guidance.

Change of sponsor legal entity (the legal responsibility for the research is transferred from one legal entity to another)2

Requires a substantial amendment to be submitted to the REC (that provided initial favourable ethical opinion) by Chief Investigator.

Refer to sponsored research amendment process.

Requires a substantial amendment to be submitted to MHRA by sponsor (or authorised sponsor contact).

Changing the sponsor results in a new CTA number being issued for the trial. It is therefore important that the change of sponsor is the only amendment made at that time. A cover letter that includes the date of transfer of responsibilities and a letter confirming the change from the old sponsor (and explanation as to the change) should accompany the amendment.

Refer to MHRA guidance.

Withdrawal or temporary suspension of sponsor declaration3 The Sponsor will ensure that the required action is taken as appropriate to the grounds for withdrawal or suspension of sponsor declaration.

[1] The definition of the active phase of a research study here is the period between when initial approvals/ permissions have been granted and prior to study being declared ended.

[2] The circumstances that have led to the change of sponsor legal entity (for example –NHS merger, or change from NHS Trust to Foundation Trust status) and details of the date when changes are to be effective should be documented by Noclor in a file note (and placed in all relevant Study/Trial Master Files (S/TMFs)).  Noclor will assess and document the risks associated with the proposed transfer of sponsor responsibilities (where transferring to a Noclor partner) as the risks will depend on who the old sponsor was (i.e was it a Noclor partner and therefore Noclor were already providing sponsor support services), the complexity of the study, the status if the study at time of transfer, the reasons for the transfer etc.

[3] The Sponsor retains the right to withdraw or suspend sponsorship at any time if deemed necessary where there are serious concerns over conduct, safety or compliance. For CTIMPs this may require one or a combination of additional actions to be taken as relevant to the grounds of suspension or withdrawal of sponsor declaration such as: implementing Urgent Safety Measures (USM); enforcing a Temporary Halt to the trial; reporting a Serious Breach and Early Termination of the trial.