Date: 04 June 2020
Time: 09:00 to 16:30
All sessions in Research Delivery Team Essentials 2019-20
This training course is delivered over two days and has been developed for Clinical Research Network-supported Research Delivery staff - an umbrella term used to capture specific roles within the Research Workforce community such as research NMAHPs; research practitioners; clinical trials administrators, co-ordinators etc.
Level: Foundation – to be undertaken within 8-20 weeks in post (as part of your induction into research practice). It is envisaged that your line manager will discuss the need to attend this training with you during your Trust induction period, when working through either your research induction portfolio or competency framework.
Aims: This course has a practical focus and has been designed to provide an introduction to working within clinical research in health & social care. It is closely linked to current clinical research induction and workforce frameworks.
Objectives: Participants will have a greater awareness of:- working in “clinical research” expectations of research Sponsors & Investigators with applicable standards (ie. GCP, SOPs) the important role they will play in successful study planning & delivery
Topics Covered: Preparing you to deliver clinical research; Preparing to Deliver Research - Clinical Research Process. Feasibility. Study Design - Types of research. Phases of CTIMPs - The Research Protocol Applications, approvals and permissions Roles and responsibilities - Delegation of duties Study Start - Patient recruitment Principles & Practicalities of Valid Informed Consent Document Management - Site files / Essential documentation - Close Out / Archiving Data Management - Data collection - Case Report Form completion - Source Data Verification Quality assurance - Standard Operating Procedures - File notes - Management of IMPs - Pharmacovigilance - Monitoring, audit and inspection.
- Line manager - to nominate a staff member, please write to your local CRN training team at training.CRNGM@nihr.ac.uk - confirming that they already have a NIHR Learn account; that they are employed in a research delivery role and that you will give them 2 full days out of the clinical area.
- Nominee - once nominated, you will receive an enrolment key so you can make your booking via NIHR Learn:- http://learn.nihr.ac.uk/