SOP C-2015 UHL serious breach - Library - University Hospitals of ...

UNIVERSITY OF LEICESTER&UNIVERSITY HOSPITALS OF LEICESTER NHS TRUSTJOINT RESEARCH & DEVELOPMENT SUPPORT OFFICESTANDARD OPERATING PROCEDURESJoint R&D Support OfficeSOP C-2015 UHLIdentifying and Reporting Deviations and Serious Breaches of GCPand/or the Protocol for Clinical Trials Sponsored and Hosted by theUniversity Hospitals of Leicester NHS TrustPCG RegistrationC26/2013OFFICE BASEJoint Research and Development Support OfficeResearch & DevelopmentLeicester General HospitalGwendolen RoadLeicesterLE5 4PW

Standard Operating Procedure: SOP C-2015 UHLIdentifying and Reporting Deviations and SeriousBreaches of GCP and/or the Protocol for ClinicalTrials Sponsored and Hosted by the UniversityHospitals of Leicester NHS TrustResearch & DevelopmentApril 20131. IntroductionThis Standard Operating Procedure (SOP) describes the process for the identification andreporting of serious breaches of GCP and/ or the approved trial protocol.Regulation 29A of the Medicines for Human Use (Clinical Trials) Regulations 2004 [StatutoryInstrument(SI) 2004/1031], as amended by the Statutory Instrument 2006/1928, contains arequirement for the notification of ‘Serious breaches of GCP or the trial protocol, by the Sponsorto the MHRA within 7 days of becoming aware of that breach’.The Sponsor has delegated the responsibility of identifying and assessing serious breachesoccurring during the day to day running of a clinical trial to the Chief Investigator. The Sponsorwill be responsible for notifying the MHRA of the serious breach.All trials should only be conducted in accordance with the approved protocol unless an urgentsafety issue arises, when action is required as per SI 2004/1031 Regulation 30 (The Medicinesfor Human Use (Clinical Trials) Regulations 2004).2. DefinitionsProtocol Deviation: A protocol deviation is any un-intended departure from the protocol, e.g. aprotocol visit date deviation, which does not result in harm to the trial subjects or significantlyaffect the scientific value of the trial. These do not need to be reported to the Sponsor but mustbe documented in the CRF and Trial Site/Master File using a signed and dated file note.Appropriate corrective and preventative action must be taken in accordance with SOP C-2014UHL in order to avoid reoccurrence of the deviation. Further guidance can be found on theMHRA website, Guidance for notification of serious breaches of GCP or the trial protocol:MHRA GuidanceSerious Breaches of the Protocol and/or GCP:Under Regulation 29A of the Medicines for Human Use (Clinical Trials) Regulations 2004 [SI2004/1031]:”29A (1) The Sponsor of a clinical trial shall notify the licensing authority in writing of any seriousbreach of –a) The condition and principles of GCP in connection with that trial; orb) The protocol relating to that trial, as amended from time to time in accordance withregulations 22 to 25, within 7 days of becoming aware of that breach.(2) For the purposes of this regulation, a “serious breach” is a breach which is likely to effect toa significant degreea)The safety or physical or mental integrity of the subjects of the trial; orb) The scientific value of the trial”.These breaches must be reported to the Sponsor immediately the Investigator becomes awareof that breach.Urgent Safety Issues:A protocol deviation/change may be implemented in response to an immediate hazard to a trialsubject without prior approval from the MHRA/REC. This is defined as an Urgent SafetySOP C-2015 UHL Identifying and Reporting Deviations and Serious Breaches of GCP and/or the Protocol for Clinical Trials Sponsored and Hosted by the University Hospitalsof Leicester NHS Trust Page 2 of 4Version 1.0Next Review: April 2015NB: Paper copies of this document may not be most recent version. The definitive version is held on INsite Documents

Measure under UK Regulation 30: “The Sponsor and Investigator may take appropriate urgentsafety measure to protect clinical trial subjects from any immediate hazard to their health andsafety. The measures should be taken immediately” The Investigator must inform the MHRAand Sponsor in writing immediately and within 3 days of deviation occurring.3. Procedure.Identifications of deviations and potential serious breaches:Deviations may be reported directly from the CI/PI /Investigator Team or during routine clinicaltrial monitoring. A written report must be submitted to the Sponsor and will include:• The title of the clinical trial• The name of the PI at the site where the deviation occurred• A full explanation of how the deviation was identified• Details of initial corrective actionsIf the Investigator is unsure whether a deviation is a potential serious breach then theymust notify the Sponsor as soon as possible and provide as much information aspossible.The Sponsor will then make an assessment to determine whether the deviation is deemed to beserious or not according to the MHRA definition described above. Appropriate corrective andpreventative action will then be implemented.The Sponsor has the responsibility to report ALL serious breaches to the MHRA andappropriate REC using the MHRA serious breach notification form within 7 days of becomingaware of the breach. Any further request for follow up information will also be dealt with by theSponsor.3. ResponsibilitiesResponsibility Undertaken by Activity1 PI/InvestigatingTeam/ ClinicalTrial Monitor2 PI/InvestigatingTeam/ ClinicalTrial MonitorPI/InvestigatingTeam/ClinicalTrial MonitorPI/InvestigatingTeam/ ClinicalTrial MonitorIdentify and document all protocol deviations in theCRF and Master/Site File, in order for appropriatecorrective and preventative actions to be taken.Report all potential serious breaches of the protocoland/or GCP to the Sponsor immediately on becomingaware of that breach, supplying as much informationas possible3 Sponsor R&D Manager If the breach is confirmed as ‘serious’ according to theMHRA definition, the Sponsor must complete a‘Notification of Serious Breach of GCP or TrialProtocol Form’4 Sponsor R&D Manager The completed notification form must be forwarded toGCP.SeriousBreaches@mhra.gsi.gov.uk ORGCP Inspectorate, MHRA, 2a Hunter house, 57Goodramgate, York, YO1 7FX within 7 days ofbecoming aware of that breachSOP C-2015 UHL Identifying and Reporting Deviations and Serious Breaches of GCP and/or the Protocol for Clinical Trials Sponsored and Hosted by the University Hospitalsof Leicester NHS Trust Page 3 of 4Version 1.0Next Review: April 2015NB: Paper copies of this document may not be most recent version. The definitive version is held on INsite Documents

4. Legal Liability StatementGuidelines or Procedures issued and approved by the Trust are considered to representbest practice. Staff may only exceptionally depart from any relevant Trust guidelines orProcedures and always only providing that such departure is confined to the specificneeds of individual circumstances. In healthcare delivery such departure shall only beundertaken where, in the judgement of the responsible healthcare professional it is fullyappropriate and justifiable – such a decision to be fully recorded in the patient’s notesand in the research site file.This table is used to track the development and approval of the document and any changesmade on revised / reviewed versionsAuthor /LeadOfficer:Reviewedby:Approvedby:DEVELOPMENT AND APPROVAL RECORD FOR THIS DOCUMENTJulie JamesJob Title: UHL Clinical TrialsMonitor and TrainerR&D Management MeetingDate Approved:27/06/2013REVIEW RECORDDateIssueNumberReviewed ByDescription Of Changes (If Any)DISTRIBUTION RECORD:Date Name Dept ReceivedSOP C-2015 UHL Identifying and Reporting Deviations and Serious Breaches of GCP and/or the Protocol for Clinical Trials Sponsored and Hosted by the University Hospitalsof Leicester NHS Trust Page 4 of 4Version 1.0Next Review: April 2015NB: Paper copies of this document may not be most recent version. The definitive version is held on INsite Documents