Finding New Commercial Studies - Crib Sheet

Study and Site Feasibility 

Guide to Site SOPs 

Jargon Busting - Glossary

Expression of Interest and the Research Location Selection Process

Confidentiality Disclosure Agreements 

Site Qualification (SQV) and Initiation Visits (SIV) - Checklist

Model Contracts 

Pharmacy IMP Management - NIHR eLearning  

This specialised Good Clinical Practice (GCP) module explores Investigational Medicinal Product (IMP) management within the context of clinical trials conducted in the NHS. It is an additional module to Introduction to Good Clinical Practice (GCP) for those who have delegated responsibility (freedom to act) for IMP management for a clinical trial.  

Fundamentals of Clinical Research for IMP Management -  NIHR eLearning

This module is aimed at staff involved in the delivery of clinical trials of Investigational Medicinal Products (IMPs) that are working under the guidance of written SOP, for example; study specific instruction, pharmacy / IMP manual, or study protocol. This learning is suitable for pharmacy staff and for non pharmacy staff. It is NOT Good Clinical Practice (GCP) training and is not suitable as stand alone training for people with delegated responsibility for clinical trials.

Site File - NIHR eLearning

Our Learning and Development Officer guides you through this package aimed at those new to site files and also more experienced staff who would like a refresher. If you are following the guided pathway through the course, we will take you through step by step.  By the end you will be able to: describe what a site file is and why it’s important, identify which essential documents are contained in a site file, explain what version control is and why it’s important, describe how to maintain an effective site file and summarise how to archive your site file effectively.

Site Delegation Log

National Contract Value Review (NCVR) - Website 

Interactive Costing Tool (iCT): How-To Video

Interactive Costing Tool (iCT): Infogram

Interactive Costing Tool (iCT): Video Playlist

National Contract Value Review Escalation Process - Infogram

Financial Disclosure Forms (FDF) 

Data Capture and Data Quality

Data Quality - NIHR eLearning

This package is aimed at those new to site files and also more experienced staff who would like a refresher.  By the end, you will be able to describe what data is, recognise the different tasks involved in data management, explain why data quality and integrity are vital to your research, complete a case report form correctly - paper or electronic and summarise the principles of ALCOAC.

Data Capture 

ALCOA+ Principles 

Recruitment Reporting / Edge eLearning 

The EDGE Programme offers a unique approach to the management and conduct of research through purpose-built software and provides research professionals with fast access to real-time data. EDGE enables users to track and manage studies from start to finish as well as providing complete control and oversight of participant recruitment. EDGE is used by all the acute partners in Kent, Surrey and Sussex you should be trained on this by your EDGE administrator at your site. Recruitment reporting is essential to ensure that you are meeting time to target on your studies. The information uploaded here feeds into centralised databases that the NIHR will use to monitor progress of studies. 

Archiving - Toolkit

An essential part of undertaking research is archiving. This needs to happen so that your documents are stored safely for years to come. It is important that archiving is undertaken in line with your Trusts SOPs and sponsor guidance. For more details click on the Toolkit above. 

Archiving - NIHR eLearning

This bitesize training video is for any research staff that have a role in Archiving a Research Study.

By the end of the the training you will understand the importance of why we archive and the associated legislation involved, explain the process of archiving, define the roles and responsibilities of the research team and consider the types of research data and how it is archived.

Sample processing

Sample Processing - NIHR eLearning

This online course aims to help individuals learn the skills and knowledge needed to deal with samples in your research role. By the end of the course participants will be able to contribute to the development and delivery of clinical research protocols as required, be aware of safety and compliance with health and safety legislation when processing clinical research samples in line with the study protocol and increase confidence and competence when handling samples, study supplies and equipment to provide high-quality data to study sponsors and be aware of the importance of following local/study policies and SOPs. 

Dangerous Goods Training - eLearning (Mayo Clinic Laboratories) 

By law, any person who causes dangerous goods to be transported by a public carrier must follow specific regulations and must have proof of training. In a laboratory environment, "send out staff," those transporting dangerous goods, and those receiving dangerous goods are among the individuals requiring training. Upon completion of this course, participants will be eligible to take an online self-assessment quiz to obtain a "Dangerous Goods Shipping" training completion certificate. 

Trial monitoring

Trial Monitoring (Video - YouTube) 

Audit and Inspection 

Working with your Clinical Research Associate (CRA) 

Safety Reporting

Safety Reporting- NIHR eLearning

This package is aimed at those new to research and also more experienced staff who would like to know more about safety reporting. By the end of this you will be able to confidently identify, classify, and report adverse events in accordance with common sponsor and regulatory requirements. Recognise acronyms and important definitions used in safety reporting. Classify events using a safety reporting decision tree. Define the differences between drug and device safety reporting. Explain what happens to safety reports behind the scenes and identify what to do if urgent safety measures are required in a study.