The SOP Controller will endeavour to notify researchers that a new or revised document has been approved for implementation via Stafflink, Q-Pulse and R&D ‘Need to Know’ emails. However, researchers should visit this page regularly to ensure that they are aware of and working to the latest SOPs relevant to their research.
NHS Fife staff wishing to be added to the Q-Pulse system for updates should contact the SOP Controller via fife.randd@nhs.scot.
SOPs
SOP02 - DISTINGUISHING RESEARCH
SOP05 - WRITING A RESEARCH PROTOCOL
SOP04 - VERSION CONTROL OF CLINICAL RESEARCH STUDY DOCUMENTATION
SOP07 - ASSESSMENT OF RISK ASSOCIATED WITH RESEARCH
SOP08 - PREPARING & SUBMITTING PROGRESS REPORTS FOR RESEARCH STUDIES
SOP09 - WRITING A PARTICIPANT INFORMATION SHEET AND INFORMED CONSENT FORM
SOP11 - PROCESS OF REVIEW FOR LOCAL MANAGEMENT APPROVAL
SOP12 - PROCEDURE FOR QUALITY ASSURANCE AUDITS
SOP13 - DELEGATION OF DUTIES AND SIGNATURE LOG
SOP14 - OBTAINING INFORMED CONSENT
SOP15 - MANAGEMENT OF CLINICAL TRIAL MEDICINES
SOP17 - VERIFYING THE IDENTITY OF PARTICIPANTS IN CLINICAL RESEARCH
SOP18 - STATISTICAL ANALYSIS PLAN
SOP19 - IDENTIFYING RECORDING AND REPORTING ADVERSE EVENTS FOR STUDIES HOSTED BY NHS FIFE
SOP20 - MANAGEMENT OF AMENDMENTS TO STUDIES SPONSORED BY NHS FIFE
SOP21 - PREPARING & MAINTAINING PAPER CASE REPORT FORMS FOR USE IN CLINICAL RESEARCH
SOP22 - MANAGEMENT OF BREACHES OF GCP OR STUDY PROTOCOL FOR CLINICAL RESEARCH
SOP24 - RESEARCH PASSPORTS AND OTHER PROCESSES FOR EXTERNAL RESEARCHERS
SOP25 - SAMPLE PROCESSING AND STORAGE
SOP27 - PREPARING AND PARTICIPATING IN A MHRA INSPECTION
SOP28 - SETTING UP STUDIES SPONSORED BY NHS FIFE
SOP29 - PREPARING AN ANALYTICAL PLAN FOR LABORATORIES ASSOCIATED WITH CLINCAL RESEARCH
SOP31 - ADVERSE EVENT REPORTING IN NON CTIMPS
SOP32 - ADVERSE EVENT REPORTING IN INVESTIGATIONS OF MEDICAL DEVICES
SOP33 - CLOSURE OF CLINICAL RESEARCH STUDIES
SOP34 - SELECTION OF SITES & INVESTIGATORS
SOP35 - ARCHIVING CLINICAL RESEARCH DATA
SOP38 - HANDLING COMPLAINTS RELATING TO THE R&D DEPARTMENT
SOP39 - ARRANGING AND TESTING MEDICAL COVER FOR CLINICAL RESEARCH STUDIES
SOP40 - LOCAL MANAGEMENT REVIEW OF AMENDMENTS TO STUDIES
SOP42 - CREATING AND MAINTAINING A TRAINING RECORD FOR RESEARCH STAFF
SOP43 - IMP TEMP MONITORING OUTSIDE PHARMACY
SOP44 - USE OF TRANSLATION SERVICES FOR RESEARCH STUDIES
SOP46 - TEMPERATURE MONITORING OF R&D FRIDGES AND FREEZERS
