Resources

Research Involving Children

Involving children in Research  

Making research central to good paediatric practice

Navigating ethical review

 

Literature review

Bandolier - Provides a summary of the best evidence-based medicine available for many topics.

 

Free Medical Journals - This site provides free access to some common medical journals.

 

Trial design

Department of Health - Latest Research Governance initiatives.

 

Clinical Trial Toolkit - This NIHR sponsored website provides a step-by-step guide to planning your clinical trial.

 

EudraLex Volume 10 - Covers the legislation, guidance and good practice that relates to the conduct of clinical trials of medicinal products for human use in the EU.

 

MHRA Good Clinical Practice guidelines - Covers the legislation, guidance and good practice that relates to the conduct of clinical trials of medicinal products for human use in the UK.

 

International Conference on Harmonisation (ICH) guidelines

 

Integrated Research Application System (IRAS) - This is a single system for applying for the permissions and approvals required for health care research in the UK. It includes data required by:

 

• Administration of Radioactive Substances Advisory Committee (ARSAC)

• Gene Therapy Advisory Committee (GTAC)

• Medicines and Healthcare products Regulatory Agency (MHRA)

• Ministry of Justice

• NHS / HSC R&D offices

• NRES/ NHS / HSC Research Ethics Committees

• National Information Governance Board (NIGB)

• National Offender Management Service (NOMS)

• Social Care Research Ethics Committee

 

CLAHRC West Midlands- The National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for the West Midlands.

 

 

Statistics

Improving Medical Statistics - This website highlights some of the potential pitfalls that can await the unwary researcher.

 

 

Ethics

Health Research Authority (HRA) - Established in December 2011, the HRA works with the MHRA & NIHR to create a unified approval process for research.

 

National Research Ethics Service - Much of the web content will be migrating to the HRA website as part of the unified research application process.

 

 

Funding

National Institute for Health Research

 

 

Designing patient information leaflets

NCCN Informed Consent Language (ICL) database - This is a comprehensive resource to assist writing and amending informed consent forms for study participants.

 

 

Training

Good Clinical Practice (GCP) is a mandatory course for everybody involved in clinical trials. It teaches the international ethical, scientific and practical standard to which all clinical research should be conducted. Specialist paediatric courses are available. It can be taken online or face-to-face, both can be accessed by the above link.