NRES Complaints Register 2012-2013

COMPLAINTS 2012-2013 - all datalast update: 17/01/2013 10:02indexName ofcomplainantName of ChiefInvestigator1 Graham R Foster Prof Graham RFosterSponsor REC REC Ref CTIMP/otherQueen Marys London -University of London South EastOfficerinvestigatingcomplaintNature of complaint11/LO/0755 other Sheila Oliver Unreasonable delay in processing a protocolamendment2 Dr Ulrike Lorch RichmondPharmacology LtdLondon - not specified Phase 1 Janet Wisely Inappropriate decision to cancel meeting onSurrey Borders09 May 2012 and other issues/ NRES3 Jenny Nutton Amgen London -Surrey Bordersnot specified Joan Kirkbride Delayed decision on amendment / poormanagement of amendment and relatedqueries4 Rachel Mills Dr Keith Muir ReNeuron Ltd GTAC GTAC 161 CTIMP Joan Kirkbride REC raised concerns within the remit ofMHRA in considering/delaying review of anamendment / delays in acknowledging andprocessing documentation5 Ken Legg Alan WinstonProfessor BrianGazzardImperial CollegeLondonUniversity of NewSouth Wales6 Simone Holley Melanie Davies ICON ClinicalResearch - Eli LillyLondon -WandsworthLondon -FulhamLondon -Westminster11/LO/153610/H0711/53CTIMPCTIMPSheila OliverGeneral lack of communication aboutchanges affecting REC. Submitted anamendment unaware that the REC office hadmoved. Revised contact information not onwebsite. Consequential delays in processingdocumentation.12/LO/0301 CTIMP Sheila Oliver Repeated delays during management ofapplication / Failure to specify the reasonsfor the opinion expressed by the REC

7 Mrs Kay Steele Dr R Bullock Pfizer Limited London -South East8 Donna Davis(Quintiles)Dr Steve ScheyJanssen-CilagInternational NVLondon -London Bridge08/H1102/2308/H1102/2409/H1102/11609/H1102/117CTIMP Sheila Oliver Poor management of four amendments /failure to keep contact information up todate / Centre post not logged10/H0804/16 CTIMP Sheila Oliver Recurrent delays in managing amendments9 Philip Willmot Mr P Willmot NottinghamshireHealthcareEast Midlands - 12/EM/0153 other Sheila Oliver Letter of unfavourable opinion not clearlyNorthamptonexpressed10 Ewa Winstanley David Hildick-Smith Gilead Sciences Ltd London -Dulwich12/LO/0062 CTIMP Sheila Oliver Loss of original documentation leading todelay in processing amendment11 Imran Malik Dr Ashley Brown Bristol-Myers Squibb London -Wandsworth --> WestLondon10/H0803/53 CTIMP Sheila Oliver Failure to respond to queries / delayedprocessing of amendment12 Louise Patterson Prof D Nutt Imperial CollegeLondon13 David R J Owen Dr D Owen Imperial CollegeLondonLondon - WestLondonLondon -Bromley11/H0707/9 other Sheila Oliver Delay in processing amendment and nonresponseto initial complaintcorrespondence12/LO/0957 other Sheila Oliver No reasons given for unfavourable opinion /application similar to previous successfulapplications

14 Dr A Sullivan Dr A Sullivan University ofCopenhagenLondon - East Surrey10/H0701/17 other Sheila Oliver Delay in processing amendment / poorresponse to enquiries15 KatherineWilliamsPratima Chowdary Novo Nordisk Ltd London -Fulham11/LO/181911/LO/1820CTIMP Sheila Oliver Objection to the unfavourable opinion given;deemed to have been made on issuesoutside the remit of the REC. Also lack ofresponse from the REC following a letterfrom the researchers in response to theunfavourable opinion.16 Dr Toni Day Prof Nigel Heaton OrganOx Limited London -Dulwich12/LO/0462 other Sheila Oliver Delay in dealing with response to request forfurther information/providing final opinion17 Kate Darwin / DrMalcolm BoyceHammersmithmedicines ResearchLondon RECs CTIMPs Sheila Oliver Availability of Co-ordinators / backup for Coordinators/ level of service during officemove / processing of NOSA within timelines/ accuracy of letters / Co-ordinator training& knowledge of SOPs / submission deadlinesfor applications / issues with outgoing mail18 Professor Peter LChiodiniProf P L ChiodiniUniversity CollegeLondon HospitalsNHS FoundationTrustLondon Bridge 11/LO/2033 other Sheila Oliver Poor supprot from REC / delay in providingadvice on revision of application previouslygiven an UFO

19 Jo Gambell,Senior Trial Coordinator20 Nuria Gonzalez-Cinca, ResearchManagerAmit NathwaniProf David EdwardsUniversity CollegeLondonAHSC Joint ResearchOfficeChelsea 12/LO/0051 CTIMP Sheila Oliver Delay in receipt of documentation for aNOSA following the closure of the CharingCross REC Centre. Documents not receivedfor one month. Also concerns aboutcommunication with the REC centreincluding delay in acknowledging the NOSAand not expediting the review whenpromised (though review completed in 32days)West London 09/H0707/98 other Sheila Oliver Delay in processing initial amendment andsubsequent modified amendment andfailure of REC staff to respond to emails andtelephone calls21 Dr Clare Relton Mr P Viksveen University ofSheffield22 Professor MartinOrrelProf M OrrellNE London NHSFoundation TrustY&tH - LeedsCentralLondon -Camden &Islington11/YH/0379 other Joan Kirkbride Committee declined to see applicantsdespite earlier invitation to attend / UFOgiven on grounds which could have beenaddressed in person / UFO based onincorrect basis12/LO/0961 other Sheila Oliver Failure of governance / care home residentsdenied access to research / REC decisionbased on anecdotal evidence / RECstigmatise residents with dementia / failureto consider expertise of researchers / delaysin managing correspondence23 RobertTownsendMr Dishnan Singh Carticept Medical Dulwich 09/H0808/98 CTIMP Sheila Oliver Delay in acknowledging six safety reportsover a period of 6 months and lack ofresponse from REC Centre staff.

24 Martin Keech Ian Chau Roche West London 12/LO/0443 CTIMP Sheila Oliver Delay in processing a NOSA25 Mike Sury Mike Sury Berkshire26 Chris Todd Chris Todd University ofManchester12/SC/0572CTIMP Joan Kirkbride UFO given as REC thought service evaluationand not a CTIMPNorthampton 12/EM/0431 0ther Sheila Oliver Concern raised that despite having a bookedteleconference call arranged for the RECmeeting, no call was received and neitherthe CI nor the student were contacted27 Nizam Mamode Nizam Mamode Guys & St Thomas's Harrow 12/LO/0877 CTIMP Sheila Oliver Several issues raised: 1. that the researcherbelieved that the REC review process forCTIMPs had been centralised at Harrow. 2.That the meeting at which the study wasreviewed was inquorate. 3. That the processof review was outside timelines identified inSOPs.28293031323334

Date ofcomplaintDate complaintacknowledgedintervalDate offinal replyintervalOutcome of investigation12/04/2012 13/04/2012 1 30/05/2012 48 Complaint upheld / unacceptable delay in processingamendment / sick leave and change of Co-ordinatorshould not affect service to researchers.13/04/2012 13/04/2012 0 23/04/2012 10 Complaint relating to the decision to cancel themeeting not upheld. Full and formal response letterfrom J Wisely (correspondence held by Sheila Reay)18/04/2012 18/04/2012 0 24/04/2012 6 Complaint upheld / unacceptable delays in processingwork via office12/04/2012 12/04/2012 0 03/08/2012 113 Referred to MHRA EAG for further advice. Confirmed,in consultation with MHRA, that issue of concern isoutside remit of GTAC. Amendment withdrawn.Modified amendment submitted for those areaswithin GTAC remit.30/04/2012 30/04/2012 0 02/05/2012 2 Apology issued for delay to processing of one of theamendments. Change of office should not affectservice to researchers.22/05/2012 29/05/2012 7 12/07/2012 51 Complaint upheld - unacceptable delay in processingnew application. Apology offered

04/05/2012 04/05/2012 0 28/05/2012 24 Poor performance acknowledged / apology offered28/05/2012 29/05/2012 1 03/07/2012 36 Complaint upheld, apology for unacceptable delay inprocessing amendments (77, 95 and 50 days). Coordinatornow working from REC Centre; additionalmonitoring and supervision of timelines in place.01/05/2012 01/05/2012 0 13/07/2012 73 Unfavourable opinion letter revised for clarity and reissued11/06/2012 12/06/2012 1 13/07/2012 32 Complaint upheld - apology made07/07/2012 07/07/2012 0 03/09/2012 58 Complaint up-held, unacceptable delays in processingamendments, inaccuracies in letters sent resulting insome requiring reissue, significant shortfalls incommunication including emails and voice mails notbeing responded to, requests for information to be resubmitted.Apology given.13/06/2012 14/06/2012 1 19/07/2012 36 Complaint upheld - apology offered; acknowledgedincreased workload of the REC02/07/2012 02/07/2012 0 03/09/2012 63Complaint partially up held. Researcher allowed torespond to the issues raised in the unfavourableopinion without full re-submission. Researcher andREC Chair and REC worked together and a favourableopinion was reached.

26/06/2012 29/06/2012 3 12/07/2012 16 Complaint upheld - apology given for delay inprocessing amendment (over 3 months) and poorcommunication from staff.03/07/2012 04/07/2012 1 13/07/2012 10 Complaint not upheld with regard to theunfavourable opinion - REC acted within it’s remit.Complaint upheld with regard to the non-response tothe letter19/07/2012 19/07/2012 0 19/07/2012 0 Complaint upheld / apology offered25/06/2012 26/06/2012 1 10/08/2012 46 Complaint partly upheld - Co-ordinators and coveravailable throughout office move - additionalresources available / NOSA delays mainly related toone REC / SOP training is carried out / submissiondeadline are routine although exceptions may bemade / no issues identified with outgoing post29/08/2012 30/08/2012 1 19/10/2012 51 Compliant upheld, investigation of emailcorrespondence revealed unacceptable delays inresponding to complainant, periods when emailswent unanswered and lack of follow and completionof actions.

29/10/2012 29/10/2012 0 03/12/2012 35 Complaint up-held and apology given. The delayoccurred during a period of handover of the REC to anew Coordinator. The handover process was not atfault, rather the application and monitoring of it , andthe NOSA should have been progressed prior to thehandover.29/10/2012 29/10/2012 0 15/11/2012 17 Complaint up-held and apology given that the REChad not followed the correct process. Appeal grantedand provisional opinion given.19/11/2012 19/11/2012 0 03/01/2013 45 Complaint up-held and apology given23/11/2012 23/11/2012 0 03/01/2013 41 1. Not up-held, the researcher mistakenly believed allCTIMPs were now reviewed by the Harrow REC as thiswas the first available slot given. 2. The meetingbecame inquarate during the course of the meeting,however the study was reviewed and the decisionratified at a quorate meeting of the REC. 3. Thereview timeline was 57 days (some delay in responseto PO and initial response incomplete). Explanatoryletter sent.0 00 00 00 00 00 00 0

0 0average interval 1.11 28

Remedial or preventative action takenBoth Co-ordinators allocated a mentor andperformance actively managedRequest for independent review by NREA Dr RichardTiner. Meeting held between HRA and RP and issuesresolved.Additional experienced support seconded to office toreduce backlogNew arrangements now in place followingdisestablishment of GTAC.Website to be updated with information about RECchanges. Co-ordinators to include information in e-mail footers.Experienced and established Co-ordinator appointed /future move of REC Centre will provide greatersupport

Correspondence corrected and reissued / mentoridentified for staff involved / contact informationupdatedCo-ordinator now working from REC Centre /additional monitoring and supervision of timelines inplace.Additional guidance to Co-ordinator and review ofunfavourable opinion letter example in minute-takingguidanceRelevant staff advised of the need for careful filing ofdocumentation and meeting timelines; additionalmonitoring and supervision of timelines in placeShortfalls discussed with Centre Manager andCoordinator. Complaint awareness session scheduledfor the London REC Centre. Staff re-deployed toassist/clear back-log of work for this REC.Administration of the REC to be moved to NottinghamREC Centre from the 1st October 2012.Chair and Co-ordinator have developed a differentsystem of working to meet timelinesno action required

Closed REC account being actively monitored untilclosed on RED; staff advised regarding communicationissues. Moving to new REC Centre where there will begreater management supervision and support.No further action required - the Chair had seen andannotated the letter. The Co-ordinator, who has nowleft, did not send a responseLetter sent / Centre reminded of correct process fordealing with complaintsTeam building day to be held to enhance coverarrangements / one Centre now closed and moved toSkipton House with enhanced management support /change of REC Co-ordinator / refresher SOP training tobe held /complaints training provided for all London REC Centrestaff 17/09/10, reiteration of the need to respond in atimely manner and complete actions. Closermanagement support provided.

Complaints training provided for all London RECCentre staff 17/09/10, reiteration of the need torespond in a timely manner and complete actions. RSSfeed added to the NRES websiteComplaints training provided for all London RECCentre staff 17/09/10, administration of West LondonREC transferred to the Nottingham REC CentreManagement of researchers attending meetingsdiscussed with REC Chair by RMNone requiredStaff concerned spoken to with regard to lack ofresponse. Training and written information providedby the Senior Coordinator with regard toacknowledgement of safety reports.

Discussed with the CM the need for vigilance admonitoring of handover when staff are leaving. Alsothe complaint referred to patients being compromisedbecause of the delay in processing the NOSA, thisexample to be used in future complaints training.Discussed with REC Chair for further learningDiscussed at OMT and ascertained that thoughtelecons may be booked during REC meetings wherethe researcher cannot attend, not all are contacted.Instruction to be included in OMEA that if a telecon isarranged, the researcher must be contacted (even ifthere are no questions for the researcher)Processes in place to reduce timelines