Archiving HEY-sponsored CTIMPs and hosted CTIMPs

Transcription

1 R&D GCP SOP 14 versin 4, R&D Department Archiving HEY-spnsred CTIMPs and hsted CTIMPs Hull And East Yrkshire Hspitals NHS Trust 2010 All Rights Reserved N part f this dcument may be reprduced, stred in a retrieval system r transmitted in any frm r by any means withut the prir permissin f Hull and East Yrkshire Hspitals NHS Trust R&D department. When this dcument is viewed as a paper cpy, the reader is respnsible fr checking that it is the mst recent versin. The current versin is available n the HEY internet Research & Develpment site Click n GCP SOPs fr HEY-spnsred CTIMPs Or the HEY intranet Research & Develpment site Click n GCP SOPs SOP reference n: R&D GCP SOP 14 Authr: J H Pacynk Current versin number and date: Versin 4, Review date: First apprved by: R&D Cmmittee Date first apprved: Target audience: Research staff, R&D staff, Medical Recrds, pharmacy clinical trials staff Distributin: R&D internet and intranet sites Signed ff by R&D Directr: Prf Nick Staffrd Signature: Signed and dated cpy kept in R&D Date: Signed ff by R&D Manager: James Ilingwrth Signature: Signed and dated cpy kept in R&D Date: Page 1 f 17

2 R&D GCP SOP 14 versin 4, This page shuld detail the versin histry fr this SOP and the main changes crrespnding t the versins. Versin Lg Versin number and date Authr Details f significant changes Versin 1, JHP Original SOP apprved by R&D Cmmittee n Versin 2, JHP Clarificatin f filing f Cnfirmatin f Receipt frm fr mnitr n page 8. Versin 3, JHP All links checked & up-dated as necessary Added t page 4 Wh shuld use this SOP: Research staff invlved with HEY-spnsred nn-ctimps may find this SOP a useful guide, althugh the SOP will need t be adapted fr the nn-ctimp study. Research staff invlved with clinical trials spnsred by an external rganisatin where the spnsr has n SOP fr archiving trial dcuments. HEY R&D SOPs are defaulted t in this case. Added t page 6, 7 & 8 - Fr hsted CTIMPs, investigatr and pharmacy respnsibilities: Where the spnsr is archiving n behalf f the PI, the PI shuld retain cntrl f the dcumentatin cntained in the Investigatr Site File and Pharmacy Study File. The ISF/PSF shuld never be sent t the spnsr. Dcuments in the ISF/PSF can nly be accessed r released frm the external archive with the apprval f the PI and pharmacy r the Trust. The PI must check this arrangement with the archive facility. Page 6 - Investigatr respnsibilities Labelling f study patients casentes with study alert sticker n the inside frnt cver. We n lnger use STOP-ALERT stickers n the frnt cver. Added t page 10 - Archivist - Hand cpies f requested dcuments t researcher at pre-arranged time. - Cmplete the Retrieval Lg in the R&D CTIMP archiving spreadsheet. Versin 4, JHP Page 8 The 5yr archiving perid and date f destructin f study files will be 5 years frm the date in part D.1 n the Declaratin f End f Trial frm. Appendices 1, 2, 5 & 6 Archiving File Ntes Head f Department t sign ff if the PI cannt be cntacted despite all effrts made t cntact the PI. Head f Pharmacy t sign ff shuld the Principal Clinical Trials Technician nt be available. Page 2 f 17

3 R&D GCP SOP 14 versin 4, Sectin n. Cntents Page n. 1 Purpse 4 2 Wh shuld use this SOP 4 3 Backgrund 4 4 Investigatr respnsibilities 6 5 Pharmacy respnsibilities 7 6 Spnsr respnsibilities - Mnitr - Archivist Medical recrds respnsibilities 11 Appendix 1 TMF Archiving File Nte 12 Appendix 2 PSF Archiving File Nte 13 Appendix 3 Cnfirmatin f receipt f study files fr archiving 14 Appendix 4 Archive Bx Cntents Frm 15 Appendix 5 I SF Archiving File Nte (hsted CTIMP) 16 Appendix 6 PSF Archiving File Nte (hsted CTIMP) 17 Page 3 f 17

4 R&D GCP SOP 14 versin 4, Please nte Fr definitins f acrnyms refer t Appendix 2 f Management f SOPs. Refer t Appendix 3 f Management f SOPs fr the standards t which clinical trials that investigate the safety and/r efficacy f a medicinal prduct are cnducted. Cntact either the R&D QA Manager r Mnitr fr access t dcuments referred t in this SOP which are nly available n the Trust s Y: drive in GCP SOPs & frms. 1 Purpse The main purpse f this SOP is t describe the prcedure fr archiving the essential study dcuments fr HEY-spnsred CTIMPs. In additin this SOP describes the archiving prcedures f essential dcuments fr hsted CTIMPs. These are clinical trials with IMPs where the spnsr is an external rganizatin e.g. pharmaceutical cmpany, anther Trust, MRC etc. Usually hsted CTIMPs are multicentre and HEY is ne f the participating sites, but they may be single centre with the HEY site nly invlved. 2 Wh shuld use this SOP This SOP shuld be used by: All research staff invlved with clinical trials invlving investigatinal medicinal prducts (CTIMPs) spnsred by Hull and East Yrkshire Hspitals NHS Trust (HEY). This includes the Chief/Principal Investigatr, ther study dctrs, research nurses, prject managers, clinical trial c-rdinatrs, data managers, administratrs etc. Clinical trials pharmacy staff technicians and pharmacists. All HEY R&D staff but particularly the staff invlved with mnitring trials. Medical recrds health recrds manager. Research staff invlved with HEY-spnsred nn-ctimps may find this SOP a useful guide, althugh the SOP will need t be adapted fr the nn-ctimp study. Research staff invlved with clinical trials spnsred by an external rganisatin where the spnsr has n SOP fr archiving trial dcuments. HEY R&D SOPs are defaulted t in this case. 3 Backgrund All the pints in this sectin cmply with UK Clinical Trial Regulatin 31A which stipulates the legal requirements cncerning the Trial Master File and archiving. Essential dcuments individually and cllectively allw the evaluatin f the cnduct f the trial and the quality f data and results prduced. Essential dcuments are listed in Eudralex Vlume 10 Clinical Trials Guidelines, Chapter V: Recmmendatin n the cntent f the trial master file and archiving. Available frm: In brief, the essential dcuments cmprise all the study dcuments including all dcuments in the Trial Master File, Investigatr Site File (hsted CTIMPs), CRFs (patient data cllectin frms), Pharmacy Study File and any ther study files. Page 4 f 17

5 R&D GCP SOP 14 versin 4, The essential dcuments serve t demnstrate the cmpliance f the investigatr, spnsr and mnitr with the UK Clinical Trial Regulatins and are thus subject t inspectin by the regulatry authrity (MHRA). Fllwing cnclusin f the study, essential dcuments including study data shuld be archived in a cmplete and legible cnditin fr a sufficient length f time t allw fr inspectin by regulatry authrities and shuld be available upn request. Fr clinical trials using IMPs with marketing authrisatins, the essential dcuments require archiving fr at least 5 years fllwing cmpletin f the trial. Archiving time is lnger fr clinical trials invlving IMPs in develpment prir t marketing authrisatin. If trials are t be included in regulatry submissins then essential study dcuments shuld be retained until at least 2 years after the last apprval f a marketing applicatin t the EU (where apprpriate). The duratin f archiving shuld be checked with the spnsr, funder r cmpetent authrity (the MHRA in the UK). Cmpletin f the trial is usually defined as the date f the last patient s last visit unless stated therwise in the prtcl. The spnsr is respnsible fr archiving the essential dcuments and access must be restricted t individuals appinted by the spnsr. Medical files f study patients als must be retained fr at least 5 years fllwing cmpletin f the trial. Fr HEY-spnsred CTIMPs During the study, the essential dcuments shuld all be kept filed in the Trial Master File, CRFs, Pharmacy Study File and Spnsr Study File. The Chief r Principal Investigatr keeps the Trial Master File and CRFs. Pharmacy maintains the Pharmacy Study File and HEY R&D keeps the Spnsr Study File. The list f cntents fr the Trial Master File and Pharmacy Study File are available frm the R&D mnitr r the HEY internet R&D site (GCP dcuments fr HEY-spnsred CTIMPs) The cntents lists cmply with Eudralex Vlume 10 Chapter V. After study cmpletin, archiving f all files will be rganized and centralised by HEY R&D. HEY R&D will cllate the Trial Master File, CRFs, Pharmacy Study File and Spnsr Study File and archive these tgether using an external archiving cmpany, Magnum Services. The duratin f archiving will be fr at least 5 years fllwing study cmpletin fr clinical trials using IMPs with marketing authrisatins. If the trial has an external funder then it is imprtant t check with the funder in case they require a lnger perid f archiving. During archiving, access t these files will be restricted t the R&D archivist and nminated deputy. HEY medical recrds department is respnsible fr retaining patients casentes. Page 5 f 17

6 R&D GCP SOP 14 versin 4, Fr hsted CTIMPs The essential dcuments frm the HEY site may be archived by the spnsr r by the principal investigatr. Archiving duratin shuld be checked with the spnsr. Where the spnsr is archiving n behalf f the PI, the PI shuld retain cntrl f the dcumentatin cntained in the Investigatr Site File. The ISF shuld never be sent t the spnsr. Dcuments in the ISF can nly be accessed r released frm the external archive with the apprval f the PI r the Trust. The PI must check this arrangement with the archive facility. If the PI archives then the site essential dcuments shuld be archived using an external archiving cmpany. HEY R&D may archive n the PI s behalf if the PI des nt already use an external archiving cmpany. 4 Investigatr respnsibilities Fr HEY-spnsred CTIMPs Maintenance f the Trial Master File and patient data during the study. The list f cntents fr the TMF is available at Labelling f study patients casentes with study alert sticker n the inside frnt cver. The mnitr will advise n this system. The sticker shuld clearly state that the patients casentes shuld nt be destryed until the allwed date f destructin. See sectin 7 belw fr an example study sticker template. Submissin f the end f trial frm (see End f Trial SOP 12) t the MHRA, REC and HEY R&D when the study has ended (cmpleted r terminated). Wrk with the study mnitr t reslve all actins fllwing the mnitr s site clsedwn visit. Check thrugh and sign ff the TMF Archiving File Nte (Appendix 1) prvided by the mnitr. The archiving file nte details; the files fr archiving, the duratin f archiving (usually a minimum f 5 years), the archive rganisatin, the name and cntact details f the archivist, hw t retrieve dcuments and the allwed date f destructin. Keep this file nte in a secure place fr future reference. A cpy will be kept in sectin 16 f the TMF and als by the archivist. Agree a suitable date with the mnitr fr cllectin f the Trial Master File and CRFs. Sign the R&D cnfirmatin f receipt frm (Appendix 3) when the mnitr cllects the study files. Reimburse R&D fr archiving the TMF and patient data fr the required perid (at least 5 years frm the end f trial). An invice fr the ttal duratin f archiving will be sent t the CI/PI at the start f archiving by R&D. After study dcuments have been archived, cntact the R&D archivist t request retrieval f archived study dcuments if necessary. The request must be cnfirmed by the Chief/Principal Investigatr. Page 6 f 17

7 R&D GCP SOP 14 versin 4, Investigatr respnsibilities cntinued Permissin will be sught frm the Chief r Principal Investigatr befre destructin f any dcuments. Fr hsted CTIMPs Check with the spnsr wh shuld archive the HEY site essential dcuments and hw lng the dcuments shuld be archived. This may already be stipulated in the study cntract. If the spnsr is archiving n behalf f the PI, the PI shuld retain cntrl f the dcumentatin cntained in the Investigatr Site File. The ISF shuld never be sent t the spnsr. Dcuments in the ISF can nly be accessed r released frm the external archive with the apprval f the PI r the Trust. The PI must check this arrangement with the archive facility. If the HEY principal investigatr is archiving the HEY site essential dcuments, then make sure an external archive cmpany is used and that access is nly restricted t the HEY principal investigatr. If HEY R&D archives n behalf f the PI, then the Investigatr Site File, CRFs, Pharmacy Study File and Spnsr Study File will be cllated and archived with Magnum. Access will be restricted t the R&D archivist with requests fr retrievals cnfirmed by the PI. The mnitr will prduce an ISF Archiving File Nte (Appendix 5) with all these details fr sign ff by the PI. 5 Pharmacy respnsibilities Fr HEY-spnsred CTIMPs Maintenance f the Pharmacy Study File during the study. The list f cntents fr the PSF is available at Receipt f a cpy f the end f trial frm (see End f Trial SOP 12) frm the study mnitr as cnfirmatin that the study has ended (cmpleted r terminated). Wrk with the study mnitr t reslve all actins fllwing the mnitr s pharmacy clsedwn visit. Check thrugh and sign ff the PSF Archiving File Nte (Appendix 2) prvided by the mnitr. The archiving file nte details; the files fr archiving, the duratin f archiving (usually a minimum f 5 years), the archive rganisatin, the name and cntact details f the archivist, hw t retrieve dcuments and the allwed date f destructin. Keep this file nte in a secure place fr future reference. A cpy will be kept in sectin 6 f the PSF and als by the archivist. Agree a suitable date with the mnitr fr cllectin f the Pharmacy Study File. Sign the R&D cnfirmatin f receipt frm (Appendix 3) when the mnitr cllects the PSF. Permissin will be sught frm the Principal Pharmacy Technician befre destructin f any dcuments. Page 7 f 17

8 R&D GCP SOP 14 versin 4, Fr hsted CTIMPs Check with the spnsr wh shuld archive the HEY site pharmacy study file and hw lng the dcuments shuld be archived. This shuld be stipulated in the study cntract. If the spnsr is archiving the HEY pharmacy study file, the PI shuld retain cntrl f the dcumentatin cntained in the Pharmacy Study File. The PSF shuld never be sent t the spnsr. Dcuments in the PSF can nly be accessed r released frm the external archive with the apprval f the PI and principal pharmacy technician. The PI must check this arrangement with the archive facility. If the HEY pharmacy site is archiving the pharmacy study file, then make sure an external archive cmpany is used and that access t the pharmacy essential dcuments is authrised by the PI and HEY principal pharmacy technician. If HEY R&D archives n behalf f the PI, then the Investigatr Site File, CRFs, Pharmacy Study File and Spnsr Study File will be cllated and archived with Magnum Archive Services. Access will be restricted t the R&D archivist with requests fr retrievals authrised by the principal pharmacy technician. The mnitr will prduce a PSF Archiving File Nte (Appendix 6) with all these details fr sign ff by the principal pharmacy 6 Spnsr respnsibilities Mnitr Fr HEY-spnsred CTIMPs At the beginning f the trial, check with the funder (if ne) that 5 years after the end f study cmpletin is sufficient fr the duratin f archiving. This shuld be stipulated in the cntract. During rutine mnitring visits and at the site and pharmacy clsedwn visits, check fr cmpletin f the Trial Master File and Pharmacy Study File. The list f cntents fr all study files is available frm Y:\Research\GCP SOPs & frms\cntents lists f study files. During rutine mnitring visits check that patients casentes have a study alert sticker n the inside frnt cver with the crrect infrmatin, including the crrect date f destructin. At the end f the trial, ensure that the PI has submitted the end f trial frm t the MHRA, REC and a cpy t R&D. The archiving perid will be fr 5 years frm the date entered in part D.1 n the end f trial frm. At the end f the trial, prepare the TMF and PSF archiving file ntes (Appendices 1 and 2). The allwed date f destructin will be at least 5 years frm the date in part D.1 n the end f trial frm. Ensure cpies f the signed TMF and PSF archiving file ntes are filed in the TMF and PSF and that the PI and principal pharmacy technician have a cpy fr future reference. Ensure the riginal signed TMF and PSF archiving file ntes are filed in the R&D ffice file: Archiving CTIMPs. Check that all actins have been reslved frm the site and pharmacy clsedwn visits. Page 8 f 17

9 R&D GCP SOP 14 versin 4, When all actins have been reslved, rganize the cllectin f the TMF and CRFs frm site and the PSF frm pharmacy. Cmplete and btain signatures n the R&D cnfirmatin f receipt frm (Appendix 3) t cnfirm cllectin f the files. File the riginal receipt frm in the R&D ffice file: Archiving CTIMPs and place a cpy in the Spnsr Study File. Advise and help the archivist prepare and arrange the files in the archive bxes accrding t the instructins prvided by Magnum Services. Check with the archivist the Archive Bx Cntents frm (Appendix 4) fr each archive bx. Fr hsted CTIMPs that are mnitred At the beginning f the trial, check with the spnsr wh shuld archive the HEY site and pharmacy essential dcuments and hw lng the dcuments shuld be archived. This shuld already be stipulated in the study cntract. The cst f archiving and wh pays shuld als be checked. During rutine mnitring visits and at the site and pharmacy clsedwn visits, check fr cmpletin f the Investigatr Site File and Pharmacy Study File. The spnsr may stipulate t use their wn cntents lists fr study files therwise use cntents lists fr HEYspnsred CTIMPs available frm Y:\Research\GCP SOPs & frms\cntents lists f study files. During rutine mnitring visits, check that patients casentes have a study alert sticker n the inside frnt cver with the crrect infrmatin, including the crrect date f destructin At the end f the trial, check with the spnsr the allwed date f destructin f the study files and cmplete the ISF and PSF archiving file ntes (Appendix 5 and 6) accrdingly. Ensure cpies f the signed ISF and PSF archiving file ntes are filed in the ISF, PSF and R&D Participating Site File and that the PI and principal pharmacy technician have a cpy fr future reference. Check that all actins have been reslved frm the site and pharmacy clsedwn visits. Send a cpy f visit reprts and riginal archiving file ntes t the spnsr. If HEY R&D is archiving, cllect ISF, CRFs and PSF using the cnfirmatin f receipt frm (Appendix 3) and help the archivist prepare the archive bxes fr archiving at Magnum as fr HEY-spnsred CTIMPs. Archivist Fr HEY-spnsred CTIMPs and hsted CTIMPs where HEY R&D is archiving. Preparatin f study dcuments fr archive Take cpies f the TMF (r ISF) and PSF Archiving File Ntes (at the frnt f these files) and file in the R&D ffice file: Archiving CTIMPs. With the mnitr, prepare and arrange the files in the archive bxes. Cmplete the Archive Bx Cntents frm (Appendix 4) fr each archive bx. Ask the mnitr t check. In the mnitr s absence ask the QA r R&D Manager. Page 9 f 17

10 R&D GCP SOP 14 versin 4, Place a cpy f the Cntents frm in a plastic wallet at the tp inside the relevant archive bx and keep a cpy in the R&D ffice file: Archiving CTIMPs. Clearly write the bx number n the tp f the Magnum archive bx. Write the R&D study reference number (in cntents) and bx number (in bx reference) n bth ends f the archive bx. Ask the mnitr t check. Cmplete the R&D CTIMP archiving spreadsheet. Up-date the ReDA database by saving a cpy f the Archive Bx Cntents Frm in a flder called Archive Dcs in the Dcument Stre. Set up an autmated n ReDA t be sent t the PI/CI r principal pharmacy technician n the allwed date f destructin requesting permissin fr the destructin f the relevant files. The archivist, mnitr, QA Manager, R&D Manager and R&D generic inbx will be put n cpy f this autmated reminder. Arrange fr cllectin f the archive bxes by Magnum. Invicing Send an invice t the Chief/Principal investigatr t reimburse R&D fr the cst f archiving the Trial Master File (r Investigatr Site File), CRFs, pharmacy and spnsr study files. This is a ne-ff payment t be paid at the start f archiving. File invices in the R&D ffice file: Archiving CTIMPs. Cmplete the Invice sectin (amunt, date sent and date paid) in the R&D CTIMP archiving spreadsheet. Request fr retrieval f dcuments Check that the request fr retrieval f study dcuments has been cnfirmed/authrized by the Chief r Principal Investigatr r the Principal Pharmacy Technician r R&D Manager. Discuss the request with the study mnitr, QA r R&D manager. Request the apprpriate archive bx frm Magnum. Phtcpy the requested dcument(s). File the riginal dcument(s) back in the Trial Master File, CRFs, Pharmacy Study File r Spnsr Study File. Make sure the researcher des nt have access t the riginal dcuments in archive bx. Hand cpies f the requested dcuments t the researcher at a pre-arranged time. Cmplete the Retrieval Lg in the R&D CTIMP archiving spreadsheet. Organize return f the archive bx t Magnum. Page 10 f 17

11 R&D GCP SOP 14 versin 4, Destructin At the allwed time f destructin, btain permissins n the Archive Bx Cntents Frm frm the Chief/Principal Investigatr, Principal Pharmacy Technician and R&D Manager. When all signatures have been btained n the Archive Bx Cntents Frm alert Magnum which bxes t destry. Cmplete the Actual date f destructin n the Archive Bx Cntents Frm. Keep all frms and crrespndence cncerning destructin f the study files in the R&D ffice file: Archiving CTIMPs. Up-date the Destructin sectin f the R&D CTIMP archiving spreadsheet. 7 Medical recrds respnsibilities Check the sticker n the inside frnt cver f patients casentes fr the allwed date f destructin. An example study sticker template: Patient invlved in (insert title) clinical trial. D nt destry ntes until year (insert date: last patient, last visit + 5 years). Cntact (insert name and department) tel. n (insert tel number) fr any queries r in case f emergency admissins. Patient entered study n Patient cmpleted study n A L E R T Retain patients casentes in paper frm until the allwed date f destructin. Page 11 f 17

12 R&D GCP SOP 14 versin 4, Versin 4/ /JP&SM Appendix 1 Brief study title: R&D ref n: Principal investigatr: ARCHIVING FILE NOTE Trial Master File Sectin 14 Eudract n: Hspital address: Date: Regarding: Archiving f the Trial Master File In rder t cmply with Regulatin 31A f the UK Clinical Trial regulatins, Hull and East Yrkshire Hspitals NHS Trust as spnsr will be respnsible fr archiving the Trial Master File and CRFs fr at least 5 years after cmpletin f the study. Study cmpletin is usually defined as the last study patient`s, last study visit. The trial mnitr will rganize the cllectin f the Trial Master File and CRFs after the site clsedwn visit. The archive rganisatin is Magnum Services, Britannia Way, Gle DN14 6ES. The archivist (respnsible persn) fr the Trial Master File will be Priyai Sivashankar. Priyai.Sivashankar@hey.nhs.uk Tel: Address: R&D Department, Office 13, 2 nd Flr, Daisy Building Castle Hill Hspital, Castle Rad, Cttingham HU16 5JQ If a member f the research team requires access t the study dcumentatin, then please cntact Priyai. Please nte that fr recall f study dcuments, standard deliveries ccur n Tuesdays and Thursdays. The cut ff time fr requests being 4pm n Mndays and Wednesdays. Emergency deliveries can be dne n the same day but at an extra cst. The allwed date f destructin will be (insert date: mnth, year). N dcuments will be destryed withut prir permissin frm (insert name) (Principal Investigatr). If after all effrts have been made t cntact the Principal Investigatr have failed, then permissin will be sught frm the Head f Department t destry the study files. (insert name) (Principal Investigatr) Sign Date (insert name) (Head f Department) Sign Date (insert name) (Clinical Trial Mnitr) Sign Date. Page 12 f 17

13 R&D GCP SOP 14 versin 4, Versin 3/ /JP&SM Appendix 2 Brief study title: R&D ref n: Principal investigatr: ARCHIVING FILE NOTE Pharmacy Study File Sectin 6 Eudract n: Pharmacy address: Date: Regarding: Archiving f the Pharmacy Study File In rder t cmply with Regulatin 31A f the UK Clinical Trial regulatins, Hull and East Yrkshire Hspitals NHS Trust as spnsr will be respnsible fr archiving the Pharmacy Study File fr at least 5 years after cmpletin f the study. Study cmpletin is usually defined as the last study patient`s, last study visit. The trial mnitr will rganize the cllectin f the Pharmacy Study File after the pharmacy clsedwn visit. The archive rganisatin is Magnum Services, Britannia Way, Gle DN14 6ES. The archivist (respnsible persn) fr this Pharmacy Study File will be Priyai Sivashankar. Priyai.Sivashankar@hey.nhs.uk Tel: Address: R&D Department, Office 13, 2 nd Flr, Daisy Building Castle Hill Hspital, Castle Rad, Cttingham HU16 5JQ If a member f the clinical trials pharmacy staff requires access t the study dcumentatin, then please cntact Priyai. Please nte that fr recall f study dcuments, standard deliveries ccur n Tuesdays and Thursdays. The cut ff time fr requests being 4pm n Mndays and Wednesdays. Emergency deliveries can be dne n the same day but at an extra cst. The allwed date f destructin will be (insert date: mnth, year). N dcuments will be destryed withut prir permissin frm (insert name) (Principal Clinical Trials Pharmacy Technician) / (insert name) (Head f Pharmacy) (insert name) (Principal Clinical Trials Pharmacy Technician) Sign Date (insert name) (Head f Pharmacy) delete if principal CT pharmacy technician is signing ff Sign Date (insert name) (Clinical Trial Mnitr) Sign.. Date. Page 13 f 17

14 R&D GCP SOP 14 versin 4, Versin 1/ /JHP Appendix 3 HEY-spnsred / hsted CTIMPs Cnfirmatin f receipt f study files fr archiving Brief study title: R&D ref n: Eudract n: Principal investigatr: Hspital address: Site Files cllected Date cllected File this frm in the R&D ffice file: Archiving CTIMPs Trial Master File Investigatr Site File CRFs patients 01 - Crrespndence file Mnitr: (insert name) Sign Date Investigatr: (insert name) Sign Date Pharmacy Files cllected Date cllected File this frm in the R&D ffice file: Archiving CTIMPs Pharmacy Study File Mnitr: (insert name) Sign Date Pharmacy: (insert name) Sign Date Page 14 f 17

15 Appendix 4 Archiving SOP R&D GCP SOP 14 versin 4, Versin 3/ /JHP HEY-spnsred CTIMP / hsted CTIMP Archive Bx Cntents Frm Cmplete electrnically Study title: R&D ref n: Eudract n: Principal investigatr: Hspital/GP address: Spnsr: Hull and East Yrkshire Hspitals NHS Trust Amend as apprpriate Written n side f archive bx Cntents RXXXX Bx Reference Als written n tp f bx Cntents X CTIMP TMF sectins 1 14 PSF sectins 1 6 SSF sectins 1 8 CRFs patients 1 Date f End f Trial Ntificatin: Allwed date f destructin: Insert names belw befre setting up ReDA autmated 1. I (insert name) as Chief/Principal Investigatr agree t the destructin f the Trial Master File (TMF) and CRFs listed abve n (insert date). Sign. Date 2. I (insert name) as Principal Pharmacy Technician agree t the destructin f the Pharmacy Study File (PSF) listed abve n (insert date). Sign. Date 3. I (James Illingwrth) as R&D Manager agree t the destructin f the Spnsr Study File (SSF) listed abve n (insert date). Sign. Date Actual date f destructin: Cmplete this date at time f destructin and keep this frm in the R&D ffice file: Archiving CTIMPs Page 15 f 17

16 R&D GCP SOP 14 versin 4, Versin 2/ /JP&SM Appendix 5 Brief study title: R&D ref n: Principal investigatr: Spnsr: ARCHIVING FILE NOTE Investigatr Site File Sectin (insert number) Eudract n: Hspital address: Date: Regarding: Archiving f the Investigatr Site File In rder t cmply with Regulatin 31A f the UK Clinical Trial regulatins, the spnsr and chief investigatr r principal investigatr r HEY R&D (delete as necessary) will be respnsible fr archiving the Investigatr Site File and CRFs fr at least 5 years (check with spnsr and chief investigatr and amend as necessary) after cmpletin f the study. Study cmpletin is usually defined as the last study patient`s, last study visit. The archive rganisatin is (insert name and address f archive cmpany). The archivist (respnsible persn) fr the Investigatr Site File will be (insert name f persn: either spnsr archivist, site archivist r HEY archivist). Tel: Address: During archiving, dcuments can nly be retrieved by cntacting the archivist. Requests fr retrievals will be lgged by the archivist. If spnsr is archiving, nly named HEY site staff (insert name: usually PI) can access the HEY site study dcumentatin. Neither the spnsr nr Chief Investigatr has access t HEY site essential dcuments. Principal investigatr shuld check and dcument this. The allwed date f destructin will be (insert date: mnth, year). N dcuments will be destryed withut prir permissin frm (insert name f Principal Investigatr). If after all effrts have been made t cntact the Principal Investigatr have failed, then permissin will be sught frm the Head f Department t destry the study files. (insert name) (Principal Investigatr) Sign Date (insert name) (Head f Department) Sign Date (insert name) (Clinical Trial Mnitr) Sign Date. (insert name) (Archivist) Sign date. Page 16 f 17

17 R&D GCP SOP 14 versin 4, Appendix 6 ARCHIVING FILE NOTE Pharmacy Study File (Hsted CTIMP) Sectin (insert number) Versin 2/ /JP&SM Brief study title: R&D ref n: Principal investigatr: Spnsr: Eudract n: Hspital address: Date: Regarding: Archiving f the Pharmacy Study File In rder t cmply with Regulatin 31A f the UK Clinical Trial regulatins, the spnsr and chief investigatr r pharmacy r HEY R&D (delete as necessary) will be respnsible fr archiving the Pharmacy Study File fr at least 5 years (check with spnsr and chief investigatr and amend as necessary) after cmpletin f the study. Study cmpletin is usually defined as the last study patient`s, last study visit. The archive rganisatin is (insert name and address f archive cmpany). The archivist (respnsible persn) fr the Pharmacy Site File will be (insert name f persn: either spnsr archivist, pharmacy archivist r HEY archivist). Tel: Address: During archiving, dcuments can nly be retrieved by cntacting the archivist. Requests fr retrievals will be lgged by the archivist. If spnsr is archiving, nly named HEY pharmacy staff (insert name) can access the HEY pharmacy study dcumentatin. Neither the spnsr r Chief Investigatr has access t HEY site essential dcuments. Principal pharmacy technician shuld check and dcument this. The allwed date f destructin will be (insert date: mnth, year). N dcuments will be destryed withut prir permissin frm (insert name) Principal Pharmacy Technician / insert name (Head f Pharmacy) delete head f pharmacy if principal CT pharmacy technician is signing ff (insert name) (Principal Pharmacy Technician) Sign Date (insert name) (Head f Pharmacy) (insert name) (Clinical Trial Mnitr) (insert name) (Archivist) Sign... Date Sign.. Date Sign Date. Page 17 f 17