Useful Documents

Useful documents

A list of useful documents, arranged alphabetically by category.

Amendments

Protocol Amendments
Information to ascertain what constitutes a substantial protocol amendment.

Protocol Amendments: Ethics Submission
Application form for notifying the Ethics Committee of protocol amendments.

Protocol Amendments: MHRA Submission form
Form for submitting protocol amendments to MHRA.

Protocol Amendments: MHRA submission procedure
Joint Project notes for informing MHRA of substantial protocol amendments.

Archiving

Archiving
Joint Project notes on archiving, storage and destruction of essential documents.

Research in the NHS: retention of records
Department of Health summary of relevant legislation, policies and common practice relating to the retention of records in research carried out in the NHS.

Consent

Informed consent
NRES guidance on Information Sheets and Consent Forms.

Informed consent in CTIMPs
NRES guidance on informed consent in clinical trials of an investigational medicinal product.

MRC Ethics Guide: Medical research involving children
MRC guidance on consent in research involving children.

MRC Ethics Guide 2007: Medical research involving adults who cannot consent
MRC guidance on research involving adults who cannot consent, including guidance for clinical trials.

CTA

Application for a CTA
Joint Project notes to help with your application for a CTA.

CTA Application form
Link to the application form on the EudraCT web site.

Guidance on the request for authorisation of a clinical trial of a medicinal product
European Commission guidance on the request for authorisation of a clinical trials of a medicinal product.

End of Trial

End of Trial Form
Form to complete at the end of the trial, if the trial does not commence, or the trial terminates early.

Clinical Trial Report information
Information on the format of the Clinical Trial Report that is to be submitted within one year of the trial ending.

EudraCT Database

EudraCT Database
European Commission Detailed guidance on the European Clinical Trials database.

About the EudraCT Database
Joint Project notes on the purpose of the EudraCT database and why a EudraCT number is important.

GCP

EU GCP Directive
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on th approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006
The Statutory Instrument transposing the EU Good Clinical Practice Directive into UK Law on 29th August 2006.

Principles of GCP
Principles of GCP as stated in the Medicines for Human Use (Clinical Trials) Regulations 2004.

GCP in non-commercial trials
Joint Project notes on GCP in non-commercial trials.

GCP in Clinical Trials
MRC Guidelines for GCP in Clinical Trials.

EU Commission guidance note on GCP
ICH Harmonised tripartite guideline for Good Clinical Practice.

Good Clinical Research

Trial Design References
List of relevant references to help with the design of your trial.

MRC Clinical Trials Guidelines
Good practice guidance documents for different types of clinical trial.

MRC Ethics Series
List of research booklets giving guidance and advice on the conduct of research in key areas.

Legislation

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
Link to download the EU Clinical Trials Directive.

Medicines for Human Use (Clinical Trials) Regulations 2004
The Statutory Instrument transposing the EU Clinical Trials Directive in to UK Law on 1st May 2004

Management

Clinical Trial Risk Assessment
Joint Project notes on how to conduct a Risk Assessment of your trial.

Trial Management Systems
Joint Project notes on how to establish and document Management Systems for your trial.

Management of a Portfolio of Trials 1
Joint Project notes introducing the topic and a summary of the primary risks to a research active organisation.

Management of a Portfolio of Trials 2
Joint Project notes on the assessment of risk.

Management of a Portfolio of Trials 3
Joint Project notes on the management of risk and recommendations for additional work.

Monitoring

Monitoring Procedures
Joint project notes on the types of monitoring procedures that are appropriate for non-commercial trials.

Trial monitoring option checklist
Joint Project checklist to use in conjunction with Joint Project notes on Trial Risk Assessment and Monitoring Procedures, to help researchers develop a monitoring plan.

Monitoring Trial Scenarios
Joint Project illustrations of appropriate monitoring procedures for different types of non-commercial trial. 

MRC

MRC statement on regulation
MRC position statement on research regulation and ethics.

NHS Indemnity

NHS indemnity arrangements for clinical negligence claims in NHS
This guideline describes the arrangemetns which apply to handling clinical negligence claimes against NHS staff (NHS indemnity).

Pharmacovigilance

Eudravigilance Clinical Trial Module
Detailed guidance on European database of Suspected Unexpected Serious Adverse Reactions.

Adverse Reaction Reporting
Detailed European Commission guidance on the collection, verification and presentation odf adverse reaction reports arising from clinical trials.

Protocol

Information required in the trial protocol
Joint Project document outlining the information that is required in the protocol to comply with the UK Regualtions.

R&D

R&D Forum Flowchart
Flowchart for the process of securing ethics committee approval and host organisational R&D approval.

Research Governance Framework

Research Governance Framework 2nd Edition
DH publishes the 2nd edition of the Research Governance Framework for Health and Social Care (April 2005)

Research Governance Framework for England and Wales
Research Governance Framework for Health and Social Care

Research Governance Framework for Scotland
Research Governance Framework for Health and Community Care

Research Governance Framework for Northern IrelandResearch Governance Framework for Health and Social Care in Northern Ireland

Sponsorship

Summary of Sponsorship Responsibilities
Joint Project document summarising the responsibilities of sponsors.

Sponsorship Responsibilities in Medicinal Trials
This Joint Project document discusses the allocation of sponsorship responsibilities under the UK Regulations for publicly funded trials.

Universities UK and Department of Health joint statement on legal responsibilities in clinical trials
Explanation of how Universities UK and Departement of Health expect the responsibilities, liabilities and risk management in publicly funded trials of medicines to be managed.

Trial Supplies

Good practice in relation to supplies for publicly funded clinical trials of medicines
Joint Project consideration of good practice for clinical trials of medicines which fall under EU Directive 2001/200/EC.

Labelling of Investigational Medicinal Products
Joint Project document discussion on the labelling requirements for investigational medicinal products (IMPs) used in clinical trials.

GMP Annex 13 - Manufacture of IMPs
European commission guidelines on Good Manufacturing Practices: Manufacture of Investigational Medicinal Products.

Trial supplies flowcharts
Joint Project flowcharts to help with the arrangements for drugs in publicly funded clincial trials.

Good practice in hospitals
This Joint Project draft document details management issues for clinical trials of medicines in NHS hospitals with particular reference to the Pharmacy.

MHRA application for Manufacturer's Authorisation
Application form and guidance for a Manufacturer's Authorisation for Investigational Medicinal Products (MA(IMP)).