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Document:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020: Difference between revisions

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<noinclude>
== References ==
{| class="wikitable" style="width:100%;"
! Reference !! Scope !! Document part !! Language !! Preview
|-
| [[Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Who should notify]] || HM || D
Who should notify || EN || D. Arrangements for notification Who should notify? The Sponsor or a person legally authorised by the Sponsor to perform this function (for example, a legal representative or contract research ...
|-
| [[Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Investigator/Institution]] || HM || D
Investigator/Institution || EN || [...] Investigator/Institution: The investigator/institution (for example, vendor, CRO or investigator site) should also have a process in place to identify and notify the sponsor of serious ...
|-
| [[Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D When should the notification be made]] || HM || D
When should the notification be made || EN || […] When should the notification be made? • Within 7 days of the Sponsor becoming aware of the breach. If the notification function has been delegated by the Sponsor to another party, for example, a ...
|-
| [[Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D What needs to be reported]] || HM || D
What needs to be reported || EN || What needs to be reported? • Any serious breach of: (a) The conditions and principles of good clinical practice in connection with that trial (as defined in UK legislation); or (b) The protocol ...
|-
| [[Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix I]] || HM || Appendix I || EN || [...] 6. For trials that are on-going in the UK, should serious breaches that occur at non-UK sites be reported? If a serious breach is identified at an investigator site outside the UK that has a ...
|-
| [[Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix II]] || HM || Appendix II || EN || Appendix II Examples of Serious Breaches Notified to MHRA (this is not an exhaustive list)
|}
</noinclude>

Latest revision as of 14:15, 16 July 2026


Document information
Reference GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020
Validity area GBR
Scope(s) HM
Document name GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL
Version / Revision 08-Jul-2020
Status Current
Document type Official guideline
Language(s) EN
Description GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL
Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors

References

 ScopeDocument partLanguagePreview
GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix IHMAppendix IEN[...]

6. For trials that are on-going in the UK, should serious breaches that occur at non-UK sites be reported?

If a serious breach is identified at …
GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix IIHMAppendix IIENAppendix II Examples of Serious Breaches Notified to MHRA (this is not an exhaustive list)…
GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Investigator/InstitutionHMD Investigator/InstitutionEN[...]

Investigator/Institution:

The investigator/institution (for example, vendor, CRO or investigator site) should also have a process in place to i…
GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D What needs to be reportedHMD What needs to be reportedENWhat needs to be reported?

• Any serious breach of:

(a) The conditions and principles of good clinical practice in connection with that trial (as def…
GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D When should the notification be madeHMD When should the notification be madeEN[…]

When should the notification be made?

• Within 7 days of the Sponsor becoming aware of the breach. If the notification function has been delegated…
GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Who should notifyHMD Who should notifyEND. Arrangements for notification

Who should notify?

The Sponsor or a person legally authorised by the Sponsor to perform this function (for example, a…
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