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 [email protected].

SOPs

 

SOP01 - PREPARATION, APPROVAL, REVIEW AND DISTRIBUTION OF STANDARD OPERATING PROCEDURES AND WORK INSTRUCTIONS

SOP02 - DISTINGUISHING RESEARCH

SOP05 - WRITING A RESEARCH PROTOCOL 

SOP04 - VERSION CONTROL OF CLINICAL RESEARCH STUDY DOCUMENTATION

SOP06 - SPONSOR AGREEMENT 

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 

SOP41 - OBTAINING APPROVAL FOR THE PROVISION AND USE OF HUMAN TISSUE SAMPLES FOR RESEARCH IN NHS FIFE

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

SOP48 - QUALITY CONTROL CHECKING OF FIFE HOSTED STUDIES