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LSTM CTS TF 005 Trial Master File Version 1.0 _FINAL_

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					FINAL




               TRIAL MASTER FILE
                                          Template


Document number                         CTS TF 005           Effective Date:         01.11.10
Version number:                         1.0                  Approved by:            N Strickland
Superseded Version Number &                                  Review Date:            01.11.11
Date:
Originator                              S Roberts            Status:                 Final




The following provides a template for how the trial master file should be compiled. At the front of
the file, include a list of each section, as a guide to contents. Each section should also include a cover
sheet which shows which documents are included. This Template should be used alongside the Trial
Master File SOP.

Please not that not all documents will be of relevance to every project – the content of the TMF will
therefore differ according to the nature of the study. For example, for clinical trials of IMPs, most of
the essential documents must legally be maintained whereas, for solely observational studies, certain
documents will not be applicable. We have tried to indicate this wherever possible. You should
therefore interpret the guide in the context of your own individual project.




CTS TF 005: Trial Master File                                                                Page 1 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL




                     LIVERPOOL SCHOOL OF TROPICAL MEDICINE



                                CLINICAL TRIAL MASTER FILE




Title of study


Given name/acronym for
trial


Sponsor

Chief Investigator

Funder
Investigator led study/
Commercial study                                Multi-centre



Co-Investigator(s)/Site Investigators

Name                            Study Site Location




CTS TF 005: Trial Master File                                  Page 2 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL




TEMPLATE TRIAL MASTER FILE

FILE CONTENTS SHEET

SECTION 1                       TRIAL SPECIFIC DOCUMENTATION
ICH GCP REQUIREMENTS
Protocol, including version number, signed and dated
Previous version of protocol
Information given to trial participants - Informed consent form (including all applicable
translations)
Completed Informed Consent Log
Copy of patient/subject information leaflet/sheet
Previous versions of patient information leaflet(s)/sheet(s)

SECTION 2                       SPONSORSHIP INFORMATION
ICH GCP REQUIREMENTS
Sponsorship agreement
Evidence of indemnity

SECTION 3                       RESEARCH ETHICS COMMITTEE APPROVAL
ICH GCP REQUIREMENTS
Copy of all correspondence with the ethics committee relating to trial
Record of all significant telephone conversations relating to trial
Copy of the original, signed ethics committee application
If multi centre study, copy of ethics committee application for study site(s)
Ethics committee approval letter, identifying version number and date of all
documents approved
Dated ethics committee approval for any substantial amendment to trial specific
documentation (including reference to version number and date of documents
approved)
Copy of annual report to ethics committee
Copy of final report to ethics committee to document end of trial

SECTION 4                       REGULATORY APPROVAL
ICH GCP REQUIREMENTS
Information on all regulatory requirements relating to the Country where trial will be
conducted
Copies of all correspondence with relevant Regulatory Authority (if applicable)
Copy of Clinical Trial Authorisation documentation (if applicable)
Copy of the end of trial notification to regulatory authority

SECTION 5                       SCREENING AND RECRUITMENT RECORD


CTS TF 005: Trial Master File                                                 Page 3 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL



ICH GCP REQUIREMENTS
Screening and enrolment logs – documenting the number of subjects enrolled
Original signed and dated informed consent forms from all subjects

SECTION 6                       RESEARCH & TRIAL PERSONNEL
ICH GCP REQUIREMENTS
Name and signature log for all personnel involved in the conduct of the trial
Signed and dated CV’s for all site staff
Task delegation log
Copy of honorary contracts (if applicable)

SECTION 7                       TRIAL SAFETY PROCEDURES
ICH GCP REQUIREMENTS
Unblinding procedure for blinded trials
Blank AE/SAE/SUSAR recording and reporting forms
Copies of completed AE/SAE/SUSAR report forms
Copy of annual safety report to regulatory authority(ies) (where applicable) and ethics
committee

SECTION 8                       INVESTIGATIONAL MEDICINAL PRODUCT (IMP)
                                INFORMATION
ICH GCP REQUIREMENTS
Investigators Brochure and/or Summary of Product Characteristics
Pharmacy agreement (if applicable)
Instructions for handling and dispensing of Investigational Medicinal Product (if not
included in protocol)
Any other reference information regarding IMP(s) in use on the study
Shipping records (if applicable)
Certificates of analysis of IMP (if applicable)
Sample of label (if applicable)
IMP drug accountability log (held in pharmacy)
Drug destruction certificate

SECTION 9                       FUNDING INFORMATION
ICH GCP REQUIREMENTS
Copy of funding arrangements
Grant details (if applicable)
Copy of financial agreements

SECTION 10                      CASE REPORT FORMS (CRF’S) DATA COLLECTION
ICH GCP REQUIREMENTS
Sample copy of CRF/data collection form to be used, detailing version number
Copies of all previous version of CRF’s/data collection forms
CTS TF 005: Trial Master File                                                Page 4 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL




SECTION 11                      TRIAL MONITORING/AUDIT/INSPECTION
ICH GCP REQUIREMENTS
Monitoring visit reports
Audit/inspection reports

SECTION 12                      LABORATORIES
ICH GCP REQUIREMENTS
Accreditation certificates of all laboratories used
Normal value references for all laboratories used
Any other reference information relating to laboratories used for the trial
Record of any retained samples/tissue taken during the trial

SECTION 13                      GENERAL CORRESPONDENCE
ICH GCP REQUIREMENTS
Copies of all other correspondence relating to the trial
Records of all other significant telephone conversations relating to the trial




CTS TF 005: Trial Master File                                                    Page 5 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL



              FRONT SHEETS FOR TRIAL MASTER FILE SECTIONS




TRIAL MASTER FILE
Title of study


Given name/acronym for
trial


Sponsor

Chief Investigator

Funder
SECTION 1                       TRIAL SPECIFIC DOCUMENTATION
                                                                INCLUDED
ICH GCP REQUIREMENTS
                                                               Y        N
Protocol, including version number, signed and dated
Previous version of protocol
Information given to trial participants - Informed consent
form (including all applicable translations)
Completed Informed Consent Log
Copy of patient/subject information leaflet/sheet
Previous versions of patient information leaflet(s)/sheet(s)




CTS TF 005: Trial Master File                                       Page 6 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL




TRIAL MASTER FILE
Title of study


Given name/acronym for
trial


Sponsor

Chief Investigator

Funder
SECTION 2                       SPONSORSHIP INFORMATION
                                                           INCLUDED
ICH GCP REQUIREMENTS
                                                          Y        N
Sponsorship agreement
Evidence of indemnity




CTS TF 005: Trial Master File                                  Page 7 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL




TRIAL MASTER FILE
Title of study


Given name/acronym for
trial


Sponsor

Chief Investigator

Funder
SECTION 3                     RESEARCH ETHICS COMMITTEE APPROVAL
                                                                 INCLUDED
ICH GCP REQUIREMENTS
                                                                Y        N
Copy of all correspondence with the ethics committee
relating to trial
Record of all significant telephone conversations relating to
trial
Copy of the original, signed ethics committee application
If multi centre study, copy of ethics committee application for
study site(s)
Ethics committee approval letter, identifying version number
and date of all documents approved
Dated ethics committee approval for any substantial
amendment to trial specific documentation (including
reference to version number and date of documents
approved)
Copy of annual report to ethics committee
Copy of final report to ethics committee to document end of
trial




CTS TF 005: Trial Master File                                       Page 8 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL




TRIAL MASTER FILE
Title of study


Given name/acronym for
trial


Sponsor

Chief Investigator

Funder
SECTION 4                       REGULATORY APPROVAL
                                                                 INCLUDED
ICH GCP REQUIREMENTS
                                                                Y        N
Information on all regulatory requirements relating to the
Country where trial will be conducted
Copies of all correspondence with relevant Regulatory
Authority (if applicable)
Copy of Clinical Trial Authorisation documentation (if
applicable)
Copy of the end of trial notification to regulatory authority




CTS TF 005: Trial Master File                                        Page 9 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL




TRIAL MASTER FILE
Title of study


Given name/acronym for
trial


Sponsor

Chief Investigator

Funder
SECTION 5                  SCREENING AND RECRUITMENT RECORD
                                                           INCLUDED
ICH GCP REQUIREMENTS
                                                          Y        N
Screening and enrolment log – documenting the number of
subjects enrolled
Original signed and dated informed consent forms from all
subjects




CTS TF 005: Trial Master File                                 Page 10 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL




TRIAL MASTER FILE
Title of study


Given name/acronym for
trial


Sponsor

Chief Investigator

Funder
SECTION 6                       RESEARCH & TRIAL PERSONNEL
                                                              INCLUDED
ICH GCP REQUIREMENTS
                                                             Y        N
Name and signature log for all personnel involved in the
conduct of the trial
Signed and dated CV’s for all site staff
Task delegation log
Copy of honorary contracts (if applicable)




CTS TF 005: Trial Master File                                     Page 11 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL




TRIAL MASTER FILE
Title of study


Given name/acronym for
trial


Sponsor

Chief Investigator

Funder
SECTION 7                       TRIAL SAFETY PROCEDURES
                                                             INCLUDED
ICH GCP REQUIREMENTS
                                                            Y        N
Unblinding procedure for blinded trials
Blank AE/SAE/SUSAR recording and reporting forms
Copies of completed AE/SAE/SUSAR report forms
Copy of annual safety report to regulatory authority(ies)
(where applicable) and ethics committee




CTS TF 005: Trial Master File                                    Page 12 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL




TRIAL MASTER FILE
Title of study


Given name/acronym for
trial


Sponsor

Chief Investigator

Funder
SECTION 8                    INVESTIGATIONAL MEDICINAL PRODUCT (IMP)
                             INFORMATION
                                                             INCLUDED
ICH GCP REQUIREMENTS
                                                            Y        N
Investigators Brochure and/or Summary of Product
Characteristics
Pharmacy agreement (if applicable)
Instructions for handling and dispensing of Investigational
Medicinal Product (if not included in protocol)
Any other reference information regarding IMP(s) in use on
the study
Shipping records (if applicable)
Certificates of analysis of IMP (if applicable)
Sample of label (if applicable)
IMP drug accountability log (held in pharmacy)
Drug destruction certificate




CTS TF 005: Trial Master File                                   Page 13 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL




TRIAL MASTER FILE
Title of study


Given name/acronym for
trial


Sponsor

Chief Investigator

Funder
SECTION 9                       FUNDING INFORMATION
                                                       INCLUDED
ICH GCP REQUIREMENTS
                                                      Y        N
Copy of funding arrangements
Grant details (if applicable)
Copy of financial agreements




CTS TF 005: Trial Master File                              Page 14 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL




TRIAL MASTER FILE
Title of study


Given name/acronym for
trial


Sponsor

Chief Investigator

Funder
SECTION 10                  CASE REPORT FORMS (CRF’S) DATA COLLECTION
                                                               INCLUDED
ICH GCP REQUIREMENTS
                                                              Y        N
Sample copy of CRF/data collection form to be used,
detailing version number
Copies of all previous version of CRF’s/data collection forms




CTS TF 005: Trial Master File                                   Page 15 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL




TRIAL MASTER FILE
Title of study


Given name/acronym for
trial


Sponsor

Chief Investigator

Funder
SECTION 11               TRIAL MONITORING/AUDIT/INSPECTION
                                                         INCLUDED
ICH GCP REQUIREMENTS
                                                       Y         N
Monitoring visit reports
Audit/inspection reports




CTS TF 005: Trial Master File                               Page 16 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL




TRIAL MASTER FILE
Title of study


Given name/acronym for
trial


Sponsor

Chief Investigator

Funder
SECTION 12                      LABORATORIES
                                                                 INCLUDED
ICH GCP REQUIREMENTS
                                                                Y        N
Accreditation certificates of all laboratories used
Normal value references for all laboratories used
Any other reference information relating to laboratories used
for the trial
Record of any retained samples/tissue taken during the trial




CTS TF 005: Trial Master File                                        Page 17 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10
FINAL




TRIAL MASTER FILE
Title of study


Given name/acronym for
trial


Sponsor

Chief Investigator

Funder
SECTION 13                      GENERAL CORRESPONDENCE
                                                            INCLUDED
ICH GCP REQUIREMENTS
                                                           Y        N
Copies of all other correspondence relating to the trial
Records of all other significant telephone conversations
relating to the trial




CTS TF 005: Trial Master File                                   Page 18 of 18
Version: 1.0
Status: FINAL
Release date: 01/11/10

				
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