Trust Research & Innovation Standard Operating Procedure

Transcription

1 Title f Standard Operating Prcedure: Dcument Summary: Dcument Authr: Target Audience: Cnsultatin: Apprval Cmmittee: Crss Reference Dcument(s): Assciated Trust Dcuments Cntact details fr further infrmatin: RDSOP03: Definitin and Delegatin f Investigatr Respnsibilities fr CTIMPs T utline the divisin and allcatin f respnsibilities, clarify bundaries f respnsibility within the research study team, and hw they shuld be dcumented Jennifer Higham Research Gvernance Manager Trust-wide and External Researchers R&I Operatinal Grup and R&I Cmmittee members R&I Cmmittee Research Apprval Plicy RDSOP8A: Pharmacvigilance fr Trust- Spnsred MHRA-regulated Clinical Trials RDSOP8B: Pharmacvigilance fr MHRAregulated Clinical Trials nt spnsred by the Trust RD SOP30 Study Cnduct Jennifer Higham, Research Gvernance Manager Jennifer.higham@gmmh.nhs.uk Mnitring Minimum Requirement Review f SOP cntent Frequency Annually Prcess fr mnitring Review by Authr, redraft, submissin t R&I Operatinal Grup Evidence Minutes f R&I Operatinal Grup Respnsible Individual(s) Head f R&I Office Respnse Cmmittee(s) Research & Innvatin Cmmittee Operating Prcedure 1 Intrductin Fr a Clinical Trial f an Investigatinal Medicinal Prduct (CTIMP) t be managed safely and effectively, it is essential that all staff invlved are aware f the anticipated extent f their invlvement and the limits t their authrity. Status: draft Next review date: 01/07/2020 Page 1 f 5

2 Internatinal Cnference n Harmnisatin Gd Clinical Practice Guidelines (ICH GCP) define an investigatr as A persn respnsible fr the cnduct f the clinical trial at a trial site. The investigatr is respnsible fr prtecting the integrity, health and welfare f the research subjects. The investigatr must be: Qualified by educatin, training and experience Thrughly familiar with the study prtcl and any investigatinal prduct(s) Aware f, and cmpliant with Gd Clinical Practice (GCP) and any applicable regulatry requirements pertaining t clinical trial cnduct, e.g. Medicines fr Human Use (Clinical Trials) Regulatins 2004 and subsequent amendments; Department f Health Research Gvernance Framewrk The investigatr, wh has verall respnsibility fr the cnduct f a study, either at single r multiple sites, is termed the Chief Investigatr (CI). Each site invlved in a study will have a lcal Principal Investigatr (PI) wh has respnsibility fr the cnduct f the study at that site. The PI at a particular site may als be the CI f the study. If a team f investigatrs cnducts a trial at a site, the investigatr respnsible fr leading the team is the PI and ther investigatrs are referred t as c-investigatrs. 2 Purpse T utline the divisin and allcatin f respnsibilities, clarify bundaries f respnsibility within the research study team, and hw they shuld be dcumented. 3 Rles and Respnsibilities 3.1 Duties within the Organisatin It is the respnsibility f the Research & Innvatin Office team (r prxy) t make Trust R&I SOPs available t all research active staff wrking n Trustapprved research studies It is the respnsibility f the study Chief Investigatr (CI) r lcal Principal Investigatr (PI) t ensure that up-t-date cpies f Trust R&I SOPs are available t research staff It is the respnsibility f the study Chief Investigatr r lcal Principal Investigatr t infrm the Research Supprt C-rdinatr f the names f all research staff invlved n a study s that cpies f SOPs can be distributed apprpriately, and t ensure that up-t-date cpies are filed in the Investigatr Site file and are available t research staff It is the respnsibility f the study Chief Investigatr r Principal Investigatr t designate if the SOPs f anther rganisatin are t be fllwed fr a study. Fr example thse f a Clinical Research Netwrk r cmmercial spnsr. If there is significant cnflict between the external SOP and the Trust R&I SOP it Status: draft Next review date: 01/07/2020 Page 2 f 5

3 is the respnsibility f the CI r PI t reslve these with the Research Office prir t starting the study It is the persnal respnsibility f all staff t fllw Trust (r the designated alternative rganisatins) prcedural dcuments. 3.2 Specific t this SOP Fr all CTIMPs Spnsred r C-Spnsred by the Trust, the PI/CI will be required t sign a list f duties delegated t him/ her by the Trust, and t cnfirm that all members f staff listed n the Delegatin f Duties lg are authrised t wrk n the trial, befre HRA apprval is given. A Template Delegatin f Duties Lg is available frm the R&I Office Fr all CTIMPs Spnsred r c-spnsred by the Trust that invlve ther sites a Spnsr Agreement is required between the site and the Trust. The CI will be required t initiate this with the Research Office and the Principal Investigatr at the ther site Fr all CTIMPs Spnsred by ther rganisatins, there must be a delegatin f duties t the Trust and t the lcal PI. This is incrprated as an Appendix t the natinal mdel Spnsr Agreement if this has been used. See fr example mdel agreements The PI, c-investigatr(s) if applicable and any assigned research practitiner (e.g. research nurse, practitiner, fficer r c-rdinatr) respnsible fr the trial must discuss and agree n the study requirements and the delegatin f duties. 4 Prcedure 4.1 When Individual trial related duties and functins must be defined, established, allcated and dcumented prir t the initiatin f a trial. This may be cnducted with a representative frm the spnsr if apprpriate. The delegatin f tasks will depend n the qualificatins and experience f the individuals in the team, and may vary frm study t study. This shuld ccur befre any trial prcedures are perfrmed i.e. During the apprval prcess During the trial set up phase At the site initiatin visit Status: draft Next review date: 01/07/2020 Page 3 f 5

4 4.2 Level and Delegatin f Respnsibility The CI r PI has verall respnsibility fr all duties utlined in the delegatin f duties agreement with either the Trust r external Spnsr. These duties will vary depending n whether the investigatr is the CI fr the study if it is spnsred/ c-spnsred by the Trust, r if they are a PI/ CI fr a trial nt spnsred by the Trust. In summary, these respnsibilities nrmally include: Ensuring the welfare and medical care f trial subjects Obtaining apprval f and cntinued cmmunicatin with regulatry bdies e.g. Ethics Cmmittee, MHRA, Trust management Cnduct f the study in cmpliance with the prtcl Crrect infrmed cnsent prcedures Administratin and management f strage f investigatinal prduct as apprpriate Ensuring that lcal management needs are met Safety reprting e.g. Adverse Events and Serius Adverse Events The accurate and timely cmpletin f trial data Archiving It is f paramunt imprtance that the investigatr in charge n site whether CI r PI, keep detailed recrds f all adverse events reprted t them and that they reprt these t the spnsr, hst institutin and regulatry authrities apprpriately (see RDSOP 8A Pharmacvigilance fr Trust-Spnsred MHRA-regulated Clinical Trials; RDSOP 8B Pharmacvigilance fr MHRAregulated Clinical Trials nt spnsred by the Trust). Any delegatin assciated with this prcedure must be well dcumented and delegatin must be made nly t apprpriately trained individuals The PI can nminate an apprpriately experienced and qualified persn, e.g. a Research Nurse, t assist in the management f the study at the investigatinal site. The allcatin f tasks t apprpriately qualified persns shuld be recrded in the Delegatin f Duties Lg with specimen signatures and the initials f all invlved. If large numbers f clinical staff are invlved in a rutine part f the trial as part f their duties e.g. delivering a study drug ver many weeks, it may be mre practical t include the senir staff member respnsible fr their cnduct in the lg, e.g. ward sister, rather than every single staff member. This must be agreed with the spnsr Sme trial related respnsibilities may als be delegated t apprpriately qualified persnnel accrding t lcal practice. This must be dcumented n the Delegatin f Duties Lg and signed and dated by the PI. Tasks Status: draft Next review date: 01/07/2020 Page 4 f 5

5 cmmnly assciated with clinical research team rles are listed in the Delegatin f Duties Lg This is an nging prcess as circumstances may change, e.g. different members f staff may becme invlved in the study The delegatin f duties lg must: List the names f all staff invlved and utline which prcedures have been delegated t them Be signed and dated by the CI r PI (whichever is based n site), and supplied t the spnsr if required Be filed apprpriately in the investigatr site file. If archived by a spnsr, a cpy must remain at the site Be cpied t the R&I Office and apprpriate pharmacies whenever it is updated If the study has an external spnsr, they shuld be made aware f the planned divisin f tasks. Cntact names and rles f ther individuals invlved in the trial (e.g. pharmacy, labratry staff) shuld als be ntified t the spnsr and kept in the investigatr site file. Additinal Infrmatin References and Bibligraphy Internatinal Cnference n Harmnisatin f Gd Clinical Practice 1996 (last accessed ) y/e6/e6_r1_guideline.pdf Department f Health Research Gvernance Framewrk fr Health and Scial Care 2005 (last accessed ) cyandguidance/dh_ Medicines fr Human Use (Clinical Trials) Regulatins 2004 (last accessed ) UKCRC Mdel Agreements: Status: draft Next review date: 01/07/2020 Page 5 f 5