Clinical Investigational Plan (CIP) for Medical Device Studies Full ...

Short Title: PROHIBIT-ICH Sponsor code: PROHIBIT-ICH01

Clinical Investigational Plan (CIP) for Medical Device Studies

Full title of Investigation:

Short title:

Version and date of Clinical Investigation Plan (CIP): Sponsor: Sponsor CIP number: Funder (s):

PRevention Of Hypertensive Injury to the Brain by Intensive Treatment after IntraCerebral Haemorrhage: a pilot randomised trial of home telemetry-guided treatment PROHIBIT-ICH

Version 4.0, 18th April 2018

University College London PROHIBIT-ICH01 Stroke Association Priority Programme Grant

Clinical Investigation Plan, 224730, version 4.0 (18/04/18) Page 0 of 54

Short Title: PROHIBIT-ICH Sponsor code: PROHIBIT-ICH01

Revision History:

Version numbers 1.0

2.0

Date 12/12/2017

Summary of revisions in the case of amendments

Template and list of amendments requested by Sponsor

Protocol Updated by [insert name & Signature] Professor David Werring Professor Peter Rothwell Shahena Butt Ian McGurgan Louise Silver

21/02/2018

Section: a.7.4 who will hand the information sheets out, who will go through this with the patients. when does the research team get involved, do they do the second approach

Shahena Butt

Section: A8 when will consent be taken, how long between receiving the PIS will the patients be expected to consent

needs to state how capacity will Shahena Butt

3.0

15/03/2018 be assessed by who and how

Clinical Investigation Plan, 224730, version 4.0 (18/04/18) Page 1 of 54

Short Title: PROHIBIT-ICH Sponsor code: PROHIBIT-ICH01

Signatures

The Chief Investigator (CI) and the JRO have discussed this Clinical Investigation Plan (CIP). The investigator agrees to perform the investigations and to abide by this CIP.

The investigator agrees to conduct the Investigation in compliance with the approved CIP, EU Good Clinical Practice (GCP) and UK Regulations for Devices (SI 2002/618; as amended) for regulated studies, the UK Data Protection Act (1998), the Trust Information Governance Policy (or other local equivalent), the Research Governance Framework (2005 2nd Edition; as amended), the Sponsor's SOPs, and other regulatory requirements as amended.

Chief investigator Professor David Werring

Signature

Co-Chief investigator

Professor Peter Rothwell University of Oxford

Signature

Sponsor Representative

Tabitha Kavoi University College London

Signature

18/04/2018 Date

23/04/2018 Date

23.04.2018 Date

Clinical Investigation Plan, 224730, version 4.0 (18/04/18) Page 2 of 54

Short Title: PROHIBIT-ICH Sponsor code: PROHIBIT-ICH01

Contents Clinical Investigational Plan (CIP) for Medical Device Studies................................................................ 0

Signatures ............................................................................................................................................ 2

Sponsor ................................................................................................................................................ 7

Principal Investigator, Coordinating Investigator and Investigation site(s) .................................... 7

A.1 Overall Synopsis of Clinical Investigation................................................................................... 9

A.2 Background and Rationale ......................................................................................................... 13

A.3 Identification and description of the Investigational Device .................................................... 13

A.4 Justification for the design of the clinical investigation........................................................... 15

A.5 Risks and benefits of the Investigational device and clinical Investigation............................ 18

A.6 Objectives and hypotheses of the clinical investigation .......................................................... 19

A.7 Design of the clinical investigation ............................................................................................ 21 A.7.1 General.............................................................................................................................. 21 A.7.2 Investigational device and comparators ............................................................................. 21 A.7.3 Subjects............................................................................................................................. 23

Inclusion criteria ................................................................................................................................... 23 Exclusion criteria.................................................................................................................................. 23 Subject Eligibility .................................................................................................................................. 24 Subject Identfication............................................................................................................................. 24

A.7.4 Recruitment ....................................................................................................................... 25 A.7.5 Randomisation Procedures................................................................................................ 25 A.7.6 Procedures ........................................................................................................................ 25

A.8 Informed Consent Process ......................................................................................................... 25

A.9 Schedule of assessments and interventions by visit ............................................................... 27 A.9.1 Laboratory Assessments and Procedures................................................................................... 27

A.10 Device accountability ................................................................................................................ 28

A.11 Monitoring Plan ......................................................................................................................... 28 Confidentiality ...................................................................................................................................... 29 Record keeping and archiving .............................................................................................................. 29

A.12 Statistical Considerations......................................................................................................... 29

A.13 Data Management...................................................................................................................... 34 A.13.1 Procedures for data review, database cleaning, and issuing and resolving data queries.. 34 A.13.2 Procedures for verification, validation and securing of electronic clinical data systems .... 35 A.13.3 Data retention. ................................................................................................................. 35 A.13.4 Clinical quality assurance................................................................................................. 35 A.13.5 Completion of Case Report Forms ................................................................................... 35 A.13.6 Retention of Documentation............................................................................................. 36 A.13.7 Training ........................................................................................................................... 36

A.14 Amendments to the CIP ............................................................................................................ 37

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Short Title: PROHIBIT-ICH Sponsor code: PROHIBIT-ICH01

A.15 Deviations from clinical investigation plan ............................................................................. 37 A.15.1 Procedures for recording, reporting and analysing CIP deviations. .................................. 37 A.15.2 Procedure for reporting any protocol deviations ............................................................... 38

A.16 Insurance ................................................................................................................................... 38 A.17 Adverse events, adverse device effects and device deficiencies .......................................... 39 a-c) Definitions ..................................................................................................................................... 39 Seriousness ......................................................................................................................................... 42 Causality .............................................................................................................................................. 42 Expectedness ...................................................................................................................................... 42

f) Procedures for recording and reporting Adverse Events and Device Deficiencies ................... 43 Investigator responsibilities: ................................................................................................................. 43

Reporting of all Adverse Events and Device Deficiencies: Investigator and Sponsor responsibilities ............................................................................................................................ 43 Progress reports .................................................................................................................................. 44 A.18 Oversight Committees .............................................................................................................. 44 A.19 Vulnerable population ............................................................................................................... 44 A.20 Suspension or premature termination of the clinical investigation ....................................... 44 A.21 Definition of End of Trial ........................................................................................................... 45 A.22 Publication policy...................................................................................................................... 45 A.23 Bibliography .............................................................................................................................. 45 Appendix 1: Schedule of Assessments............................................................................................ 49 Appendix 2: Cognitive functional change (modified mentreal cognitive assessment)................. 50 Appendix 3: EQ-5D Questionnaire .................................................................................................... 52 Appendix 4: Home BP participant acceptability questionnaire ...................................................... 54

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