SUMMARY OF CLINICAL TRIAL SYSTEMS (SCTS)

SUMMARY OF CLINICAL TRIAL SYSTEMS (SCTS) Please note, the following information is requested specifically in relation to your clinical trial work within the UK, and should be provided within 28 days. If you require an electronic copy of this document please contact the Welwyn Office. General Requirements of SCTS Dossier By preference, information should be submitted electronically (for example on secure CD-ROM in common industry standard software packages) with a single paper copy. If it is not possible to produce the package in electronic format please state so. A list of contents should be included that gives clear document references and the total number of pages for each document supplied (to enable an initial completeness assessment on receipt; i.e. each page need not necessarily be numbered provided this assessment can be made). Please limit the SCTS to ONE lever-arch file. A checklist is provided for you to review your SCTS for completeness prior to submission to the MHRA. SECTION 1 Item 1 • Organisation charts with staff names and brief summaries of responsibilities (directly related to the activities in Section 2), if not obvious from department/function name. Item 2 • A list of all your SOPs/Work Instructions and other documented procedures that cover the conduct of clinical trials in the UK. Please provide reference number, title, issue number/date. Item 3 • A copy your procedure(s) relating to Adverse Event Reporting from clinical trials. NOTE: Additional SOPs may be requested by the Inspector prior to the inspection, please be prepared to provide these electronically. Item 4 • A list of all computer systems used in the conduct of clinical trials (databases, EDC etc) and their current release number and date of release, last release number and date of release, validation status. Page of Item 5 • A spreadsheet/table of clinical trials of Investigational Medicinal Products from 01 May 2005. The requirements of this spreadsheet/table are below. NOTE: Where relevant, an Inspector will contact the named personnel (Section 2) to provide further specific information, such as a clinical trial protocol and other essential documents, on selected trials prior to the inspection. Title of Column Sponsor Sponsor Protocol/Trial Reference Number EudraCT Number Trial Phase CTA Number IMP Status in the UK Protocol Title Chief Investigator Name Number of UK investigator Sites Number of Subjects in the UK Start Date in the UK End Date in the UK ( Planned/Actual Recruitment) First site initiated/planned initiation date Last subject followed up (or planned date) Planning (protocol development, approvals being sought), Live (at least one site initiated in UK and subject recruitment may commence/has commenced), Completed (all subjects recruited and followed up), Reported (Statistics Report and/or CSR issued), Terminated Early (please give reason), Submitted (CSR submitted to EU Regulatory Agency) Unlicensed (anywhere),UK Unlicensed (not licensed in the UK, but is elsewhere), Unlicensed Use (UK Licence, but used in new indication), Licensed Use I, II, III, IV Column Number 1 2 3 4 5 6 7 8 9 10 11 12 Details (if your organisation is not the sponsor e.g. you are a CRO) 13 Current Status in the UK 14 15 Number of SAEs/SUSARS reported in the UK Pivotal Study Indicate if study is planned for submission to MHRA or other EU Regulatory Authority Page of SECTION 2 This information is essential to fee category determination, please use the activity descriptions listed, in preference to any in-house terminology you may currently employ. This section provides us with an over-view (with location) of all company facilities located within the UK involved in clinical trial activities, including key service providers*, CROs* and support services* (as necessary in a generic form). Item 1 Your Organisation Name & Address Telephone Number Fax Number Web Site Address Direct Telephone Number E-Mail Address Primary Contact Name, Job Title & Address (if different from above – the inspector will liaise with this person to organise the inspection) Please indicate (by deleting as applicable) which activities are performed by your organisation (at the site named above) in the conduct of clinical trials in investigational medicinal products. Archiving Project Management Quality System (QA/SOPs) Training Statistics Laboratory Study Monitoring Clinical Trial Reporting Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Contract and Agreement Preparation Use of Computer Systems Data Management Regulatory Affairs (e.g. CTAs, submissions ...) Investigational Medicinal Product Management Clinical Trial Pharmacovigilance &/or Safety Reporting Filing of Essential Documents (Trial Master File) Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Please indicate (by deleting as applicable) which activities are relevant to your organisation but are performed at an alternative location (please specify location(s) and or relevant contact details in tables in item 2). Archiving Project Management Quality System (QA/SOPs) Training Statistics Laboratory Study Monitoring Clinical Trial Reporting Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Contract and Agreement Preparation Use of Computer Systems Data Management Regulatory Affairs (e.g. CTAs, submissions ...) Investigational Medicinal Product Management Clinical Trial Pharmacovigilance &/or Safety Reporting Filing of Essential Documents (Trial Master File) Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Page of Item 2 SUPPORTING SITE/ORGANISATION FOR: Name & Address Telephone Number Fax Number Web Site Address Direct Telephone Number E-Mail Address Contact Name, Job Title & Address (if different from above) SUPPORTING SITE/ORGANISATION FOR: Name & Address Telephone Number Fax Number Web Site Address Direct Telephone Number E-Mail Address Contact Name, Job Title & Address (if different from above) SUPPORTING SITE/ORGANISATION FOR: Name & Address Telephone Number Fax Number Web Site Address Direct Telephone Number E-Mail Address Contact Name, Job Title & Address (if different from above) Page of Item 3 SUMMARY INFORMATION OF YOUR ORGANISATION’S CLINICAL TRIAL SYSTEMS For the following section, please provide a brief summary to explain how your organisation functions in relation to clinical trials. These should be no longer than 1 side of A4 paper per section below. Please do NOT reference procedures and attach them. The use of diagrams/flowcharts to illustrate processes is highly recommended where appropriate. This section is for you to explain your organisation to the Inspector in relation to the activities marked in items 1 and 2. 1. Project Management Please provide details of how your organisation manages clinical trials. Who is responsible? Where are they located? How is the conduct of the trial managed & tracked etc.? 2. Quality System What is the structure of quality system? controlled? Has it different levels? Who manages it? What documents are 3. Clinical Quality Assurance How is quality assurance of your clinical trial activities organised? Who is responsible, where are they based? 4. Contract and Agreement Preparation Who is responsible for sourcing contractors, arranging contracts with them? If you are a CRO, how are sponsor contracts arranged – who does this? What systems are in place for management of subcontractors? 5. Clinical Trial Monitoring How is monitoring of your clinical investigator sites arranged? Where are monitors based? Who is responsible for monitoring activities? 6. Computer Systems Who is responsible for computer systems used in clinical trials (in reference to systems listed)? Where are servers located? What information/data is/are stored where? 7. Data Management & Statistics Where are data management activities conducted and who is responsible? What type of data collection systems are used (e.g. paper, EDC)? Where is the statistical input into clinical trials conducted? 8. Pharmacovigilance Is there a specific dept responsible for pharmacovigilance for clinical trials? What activities are performed by clinical operations? Who reports what to where? 9. Investigational Medicinal Products (IMP) Where are IMPs manufactured? Who is responsible for ordering? Where are they stored? Where is the QP who provides technical certification based? What is the process for release to investigator sites? 10. Clinical Trial Reporting How are clinical trials reported? Where are facilities and medical writers located? 11. Regulatory Affairs Who is responsible for submission of the CTA and any amendments? What other activities are performed by this group in relation to the conduct of clinical trials? 12. Trial Master File Where is the TMF located? Is it paper or electronic? How will inspectors gain access? Who is responsible for its maintenance? 13. Laboratories How are laboratory requirements organised? Is there an in-house facility? Who is responsible? 14. Archiving Is there an onsite facility? What happens to essential documents (paper/electronic) at the trial end? Page of