4) Pre-Study (P) Table of SOPs for pre-study and associated documents SOP Associated document(s) P1 Feasibility and site selection P2 Trust Sponsorship of studies P3 Gaining and maintaining the authorisations for conducting research P4 Trial Registries P5 Investigator Brochure P6 Risk Assessment P7 The use of human tissue in research P8 Document & Version Control P9 Trial Master File & Investigator Site File P10 Delgation of duties P11 Research Passports P12 Gaining permission for research involving medical exposures (using Ionising Radiations) P13 Database management, security, design and validation P14 Computerised Systems for Supporting Clinical Trials P15 Case Report Form Design P16 Data Management & IDMC P17 Statistical Analysis Plan P18 Randomisation & Blinding P19 Access and use of REDCap Community P20 Preparation and maintenance of an ISF ISF Contents List Template 2022
