Scientific and Risk Assessment Meeting - Accord - University of ...

ACCORDNHS Lothian R&D andThe University of EdinburghWork Instruction Number: GS001-W03v2.0Effective Date: 15/FEB/2012Scientific and Risk Assessment (SARA) MeetingWI NUMBER:GS001-W03VERSION NUMBER: 2.0EFFECTIVE DATE:RELEASE DATE:01/February/201215/February/20121. FOREWORDThis work instruction details the purpose of and procedures to be followed at theweekly SARA meeting. The purpose of the meeting is:To review and potentially grant Management Approval (MA) to new studiesthat have been subject to a SARA review (see GS001-W02 – ResearchReview)To review the progress of studies that have more than 21 days showing onthe R&D (Research and Development) clock since the study was entered onthe database and deemed ready for review.To allocate studies that are ready for SARA review to a reviewerTo discuss any other relevant research business relating to ACCORD andNHS Lothian policies, and study specific issues (this will be managed by theChairperson)The meeting will be chaired by the Principal R&D Manager, or designee, and theinvited attendees include but are not limited to:South East Scotland Research Ethics Committee Scientific OfficerRepresentative(s) of ACCORD Clinical Trial Monitor/sNHS Lothian support department RepresentativesNHS Lothian Support Service Coordinator(s)Page 1 of 3

ACCORDNHS Lothian R&D andThe University of EdinburghWork Instruction Number: GS001-W03v2.0Effective Date: 15/FEB/2012Representative(s) of NHS Lothian R&DACCORD Director and/or deputy DirectorEdinburgh WTCRF Representative(s)Representative(s) of UoE (University of Edinburgh) Research GovernanceThe meeting must have a minimum of five attendees. Minutes are recorded by theR&D administrative assistant or designee.The meeting will be quorate if 5 people are present one of which must be thePrincipal R&D Manager or, the Research Governance Coordinator or the Capacityand Capability Manager or, the ACCORD Director or the deputy Director.. If there isno quorum, the meeting will be rescheduled or business will be deferred to the nextmeeting.2. INSTRUCTIONSThe agenda for the meeting will include a list of attendees, approval of previousminutes, studies to be discussed, studies to be handed out, studies approved withoutSARA presentation any other business (AOB) and date of next meeting.2.1 New StudiesStudies will be presented in turn by each SARA reviewer. All attendees will then begiven the opportunity to ask questions about the study, and any issues that areraised will be discussed until a resolution is agreed.If the individual that carried out the SARA review is absent, the study will bepresented by the Chairperson using the review notes on file written by the SARAreviewer.The attendees will, during the course of the meeting, decide upon whether it isappropriate for the studies presented to be granted MA and identify any issues thatrequire further action prior to approval being given.For studies deemed ready for MA, the letters will be signed at the meeting by theACCORD deputy Director. In the absence of the ACCORD deputy Director, theACCORD Director will sign the letters. If both the ACCORD Director and ACCORDdeputy Director are absent, the letters will be given to their Personal Assistant (PA) toobtain a signature when possible, and the letter date will be amended accordingly. Ifthe ACCORD Director and ACCORD deputy Director are both absent and expectedto be so for over a week, the aforementioned PA will organise for the letters to besigned by the Medical Director or designee.If it is decided that the study is not yet ready for approval, the reviewer will note therequired actions on the study tracking sheet, together with who will be responsible forcarrying out the actions. It will also be noted whether the study needs to return to afuture SARA meeting for further discussion, or if the approval letter can be issuedonce the actions have been completed.Page 2 of 3

ACCORDNHS Lothian R&D andThe University of EdinburghWork Instruction Number: GS001-W03v2.0Effective Date: 15/FEB/20122.2 AmendmentsSponsor sign-off for amendments is performed in accordance with work instructionGA001-W05 (Amendments). If the Sponsor’s representative has any issues beforedeciding if sponsorship should be continued on the basis of the proposedamendment, the Sponsor’s representative may discuss such issues with SARAattendees to seek advice, raise a specific question or seek verification.2.3 Studies to be allocatedStudies that have had a governance review completed and are ready for SARAreview will be handed out by the Chairperson to reviewers for presentation at thefollowing week’s meeting. Studies are allocated to the reviewers on aworkload/availability basis.2.4 Over 21 Day trackingAll studies that SReDa demonstrates have been registered (with validdocumentation) for more than 21 days will be reviewed. A list of the studies will bebrought to the meeting by the Chairperson and handed out to all attendees. Thereasons why these studies are not moving forward in the review process will bediscussed and actions to remedy any delays will be agreed.2.5 AOBAt the end of the meeting, attendees have the opportunity to raise any otherbusiness. The Chairperson and ACCORD deputy Director will advise if the issue isnot appropriate for discussion at the SARA Meeting and, if so, when and how theissue can be discussed.Minutes from the meeting will be emailed to all attendees within 4 working days of themeeting. MA letters will be scanned and emailed to the PI/CI, and copied to anyrelevant parties – e.g. support departments, heads of service and the QA Manager.3. REFERENCESGS001-W02 – Research ReviewGS001-W05 – AmendmentsGS002 – Study AmendmentsPage 3 of 3