Appendix III b – Information to be submitted with a notification of a serious breach: Regulation (EU) No 536/2014

A. GENERAL INFORMATION

A.1

Status of the investigation of the serious breach

Concluded ☐                   Ongoing ☐

Estimated date of next follow up (if known):

A.2

Clinical trial title

A.3

Type of clinical trial

Commercial ☐           Non-commercial ☐

A.4

Inclusion of the clinical trial in a regulatory procedure (marketing authorization / variation)

Please specify if the clinical trial is part of a marketing authorization or variation application or if it is planned to be included in such an application. If included in a regulatory procedure, please specify the product and procedure number.

A.5

Are other clinical trials impacted by the same serious breach?

No ☐      Not Known ☐      Yes ☐

If Yes, please specify the EU CTR number:

(The reporter is requested to indicate in this section if they are aware of other clinical trial(s), registered in CTIS, impacted by the same serious breach)

A.6

Details of the site where the serious breach occurred

Please fill in in CTIS also the contact details of the site (tel., email)

A.7

MS most affected by the serious breach

Please indicate the MS most affected by the serious breach. According to the decision tree described in section 4, if the clinical trial is authorised in one MS only, that MS is the most affected; otherwise, it is identified answering the questions below. Please include the name of this MS in the title of the serious breach report.

Does the serious breach affect only one MS?

 Yes ☐      If Yes, please indicate the AMS.

No ☐ If No, please indicate the AMSs and answer to the next question.

Did the serious breach occur in a specific MS (i.e. if it occurred in a laboratory, in an interactive response technology (IRT) provider etc.)?

Yes ☐    If Yes, please indicate the MS.

No ☐ If No, please answer the following question.

Is there a MS with a larger number of trial participants (i.e. the MSC with the largest number of actually enrolled subjects or, in case no participants has been enrolled jet, the MSC with the largest number of proposed participants)

Yes ☐   If Yes, please indicate that MS and the number of trial participants for each MSC.

No ☐   If No, please justify; in this case, “No most affected MS” should be indicated in the title of the serious breach report.

B. DETAILS OF THE SERIOUS BREACH

B.1

Brief description of the serious breach

Please describe here the serious breach, or indicate reference to the CTIS field or to an attached document if the information is already described elsewhere in a comprehensive manner.

B.2

(Potential) impact of the serious breach

In addition to the areas impacted by the serious breach which are mentioned in CTIS, please indicate the sub-category (Consent Form / confidentiality / IMP / approval issues, etc.)

B.3

Other relevant details / information

C. DETAILS OF THE ACTION TAKEN/PLANNED

 For each of the following sub-section if details are not known at the time of report, a statement of when they will be available and submitted as a follow-up report should be provided.

C.1

Impact Assessment

The extent of the impact should be investigated and reported: full details of the impact assessment, what has been looked at and how this has been done i.e. methodology should be included here.

C.2

Root Cause Investigation

Describe the Root Cause Investigation and results/outcomes of this investigation.

C.3

Corrective and preventive actions (CAPA) plan

CAPA plan should include any actions already taken; for each action, the following should be reported: who is responsible for the action (Sponsor, CRO, CRA, site etc.), timeline for implementation, if already concluded or pending. The CAPA plan should also include how this incident will be documented in the TMF.

C.4

Actual Impact

The actual consequences of the serious breach should be reported, explaining for example, if the action partially or totally prevented the “potential impact” (reported in section B) from occurring, if corrective action are still possible to ensure safety of the affected trial participants, or to ensure the reliability of the data.