R&D SOPs
SOPS
- SOP01 - PREPARATION APPROVAL AND REVIEW OF SOPs & WIs (v5) Final.pdf
- SOP02 DISTINGUISHING RESEARCH (V3) Final
- SOP05 WRITING A PROTOCOL (V2) Final
- SOP06 SPONSOR AGREEMENT (V3) Final
- SOP07 ASSESSMENT OF RISK ASSOCIATED WITH RESEARCH (V1) Final
- SOP07 ASSESSMENT OF RISK ASSOCIATED WITH RESEARCH (V2) Final
- SOP09 WRITING A PARTICIPANT INFORMATION SHEET AND INFORMED CONSENT FORM (V2) Final
- SOP12 PROCEDURE FOR QUALITY ASSURANCE AUDITS (V2 ) Final
- SOP13 DELEGATION OF DUTIES AND SIGNATURE LOG (V3) Final
- SOP14 OBTAINING INFORMED CONSENT (V3) Final
- SOP15 MANAGEMENT OF CLINICAL TRIAL MEDICINES (V3) Final
- SOP17 VERIFICATION OF IDENTITY OF TRIAL PARTICIPANTS (V3) Final (1)
- SOP17 VERIFICATION OF IDENTITY OF TRIAL PARTICIPANTS (V3) Final
- SOP17 VERIFYING THE IDENTITY OF PARTICIPANTS IN CLINICAL RESEARCH (V2) Final
- SOP18 STATISTICAL ANALYSIS PLAN (V2) Final
- SOP18 STATISTICAL ANALYSIS PLAN (V3) Final
- SOP19 IDENTIFYING RECORDING AND REPORTING ADVERSE EVENTS FOR CTIMPS (V2) Final
- SOP19 IDENTIFYING RECORDING AND REPORTING ADVERSE EVENTS FOR HOSTED STUDIES (V3) Final
- SOP20 MANAGEMENT OF AMENDMENTS TO STUDIES SPONSORED BY NHS FIFE (V3) Final
- SOP20 MANAGEMENT OF AMENDMENTS TO STUDIES SPONSORED BY NHS FIFE (V4) Final
- SOP21 PREPARING & MAINTAINING PAPER CASE REPORT FORMS FOR USE IN CLINICAL RESEARCH (V2) Final
- SOP24 RESEARCH PASSPORTS AND OTHER PROCESSES FOR EXTERNAL RESEARCHERS (V2) Final
- SOP24 RESEARCH PASSPORTS, HONORARY RESEARCH CONTRACTS AND LETTERS OF ACCESS (V3) Final
- SOP25 SAMPLE PROCESSING AND STORAGE (V3) Final
- SOP27 PREPARING AND PARTICIPATING IN A MHRA INSPECTION (V2) Final
- SOP28 SETTING UP STUDIES SPONSORED BY NHS FIFE (V3) Final
- SOP29 PREPARING AN ANALYTICAL PLAN FOR LABORATORIES ASSOCIATED WITH CLINCAL RESEARCH (V2) Final
- SOP31 ADVERSE EVENT REPORTING IN NON CTIMPS (V2) Final
- SOP32 ADVERSE EVENT REPORTING IN INVESTIGATIONS OF MEDICAL DEVICES (V2) Final
- SOP33 CLOSURE OF CLINICAL RESEARCH STUDIES (V2) Final
- SOP34 SELECTION OF SITES & INVESTIGATORS (V2) Final
- SOP34 SELECTION OF SITES & INVESTIGATORS (V3) Final
- SOP35 ARCHIVING CLINICAL RESEARCH DATA (V3) Final
- SOP38 HANDLING COMPLAINTS RELATING TO THE R&D DEPARTMENT (V2) Final
- SOP39 ARRANGING AND TESTING 24 HOUR MEDICAL COVER (V2) Final
- SOP40 LOCAL MANAGEMENT REVIEW OF AMENDMENTS TO STUDIES (V4) Final
- SOP41 OBTAINING APPROVAL FOR THE PROVISION AND USE OF HUMAN TISSUE SAMPLES FOR RESEARCH IN NHS FIFE (V2) Final
- SOP41 OBTAINING APPROVAL FOR THE PROVISION AND USE OF HUMAN TISSUE SAMPLES FOR RESEARCH IN NHS FIFE (V3) Final
- SOP43 IMP TEMP MONITORING OUTSIDE PHARMACY (V2) Final (1)
- SOP43 IMP TEMP MONITORING OUTSIDE PHARMACY (V2) Final
- SOP44 Use Of Interpreting Services For Research Studies (V2) Final
- SOP44 USE OF TRANSLATION SERVICES FOR RESEARCH STUDIES (V1) Final
- SOP46 TEMPERATURE MONITORING OF R&D FRIDGES AND FREEZERS (V1) Final
- SOP48 QUALITY CONTROL CHECKING OF FIFE HOSTED STUDIES (V1) Final
- SOP49 MANAGEMENT OF SUSPECTED RESEARCH MISCONDUCT (V1) Final
- SOP11 PROCESS OF REVIEW FOR LOCAL MANAGEMENT APPROVAL (V4) Final
- R&D SOP08 PREPARING & SUBMITTING PROGRESS REPORTS(V5) Final
- R&D SOP34 SELECTION OF SITES & SITE ACTIVATION (V4) Final