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Clinical Trial Authorisation (CTA)

Clinical Trials of Investigational Medicinal Products (CTIMPs) should be categorised into either Type A, B or C by the Chief Investigator according to the MRC/DH/MHRA Risk Adaptive Approaches for CTIMPs.  The category relates to the risks to participants associated with the IMP (Type A are lowest risk, Type C are highest risk).  The IMP risk category will be confirmed by Noclor during the risk assessment process (after a sponsorship request has been submitted).

Clinical Trial Authorisation (CTA) applications (as relevant to Type A, B or C) can only be made once sponsorship has been formally declared, funding has been confirmed and the protocol has been finalised1. See below for CTA submission requirements for each Type of CTIMP.

Prior to preparing a CTA application, a unique EudraCT number must be obtained from EudraCT by the Chief Investigator.

The CTA submission must be made by an authorised Noclor Sponsor Representative (or by someone authorised to submit the request on Noclor’s behalf). Noclor does not have an in-house clinical trial pharmacy team so outsource this expertise to a third party (on a trial-by-trial basis) to ensure sponsor oversight of all aspects of CTA applications and IMP management in CTIMPs. 

If the Chief Investigator plans to withdraw the request for a Clinical Trial Authorisation (CTA) at any point prior to the MHRA having reached a decision on authorisation (either acceptance or non-acceptance) they should contact Noclor Sponsor Representative so that the appropriate action can be taken.

Type A

Type A 

Risks are no higher than that of standard medical care

Trials involving medicinal products licensed in any EU Member State if; product used within licensed range of indications, dosage and form (or established off-label use with published evidence)

A CTA for Type A trials can be obtained through the MHRA notification scheme. For details on what documents are required for a CTA submission through the notification scheme refer to the relevant MHRA guidance.  There is no MHRA fee for the notification scheme.

CTA submissions must be made by an authorised Noclor Sponsor Representative (or by someone authorised to submit the request on Noclor’s behalf). Complete electronic CTA submission packs including a label template (or justification for absence of labelling) and a cover letter (unsigned) should be prepared by the Chief Investigator and sent to the Noclor Sponsor Representative. The CTA application form should be completed through IRAS

The Noclor Sponsor Representative (or authorised delegate will check the CTA submission for completeness, authorise and submit to MHRA. 

With this scheme the notification will be acknowledged by the MHRA within 14 days of valid application with either:

  • a No Objection to Notification letter to say that the trial may go ahead, at which point the CTA on becomes valid

OR

  • If the MHRA raises an objection to the notification then the submission enters the standard process for assessment of a Clinical Trial Authorisation (CTA) application. The assessment will be performed within 30 days of the initial valid submission.

 

A signed copy of the CTA application and all relevant correspondence will be forwarded to the Chief Investigator for filing in the Trial Master File(TMF).

Type B

Type B

Risks are somewhat higher than that of standard medical care

Trials involving medicinal products licensed in any EU Member State if: product used for a new indication or with substantial dosage modifications or in combinations for which interactions are suspected

For Type B trials, a CTA application will be fully assessed by the MHRA. For details on what documents are required for a full CTA submission refer to the relevant MHRA guidance. 

CTA submissions must be made by an authorised Noclor Sponsor Representative (or by someone authorised to submit the request on Noclor’s behalf). Complete electronic CTA submission packs including a label template (or justification for absence of labelling) and a cover letter (unsigned) should be prepared by the Chief Investigator and sent to the Noclor Sponsor Representative. The CTA application form should be completed through IRAS

The Noclor Sponsor Representative (or authorised delegate will check the CTA submission for completeness, authorise and submit to MHRA. 

Any fees that require paying for the CTA submission will be made by Noclor and re-charged to the relevant budget.

The initial response (acceptance or non-acceptance) will be given within 30 days of receipt of a valid application.

A signed copy of the CTA application and all relevant correspondence will be forwarded to the Chief Investigator for filing in the Trial Master File (TMF).

Type C

Type C

Risks are markedly higher than that of standard medical care

Trials involving a medicinal product not licensed in any EU Member State

For Type C trials, a CTA application will be fully assessed by the MHRA. For details on what documents are required for a full CTA submission refer to the relevant MHRA guidance. 

CTA submissions must be made by an authorised Noclor Sponsor Representative (or by someone authorised to submit the request on Noclor’s behalf). Complete electronic CTA submission packs including a label template (or justification for absence of labelling) and a cover letter (unsigned) should be prepared by the Chief Investigator and sent to the Noclor Sponsor Representative. The CTA application form should be completed through IRAS

The Noclor Sponsor Representative (or authorised delegate will check the CTA submission for completeness, authorise and submit to MHRA. 

Any fees that require paying for the CTA submission will be made by Noclor and re-charged to the relevant budget.

The initial response (acceptance or non-acceptance) will be given within 30 days of receipt of a valid application.

A signed copy of the CTA application and all relevant correspondence will be forwarded to the Chief Investigator for filing in the Trial Master File (TMF).

[1] CTIMP protocols must include a signature page with Sponsor Representative as a required signatory