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For your chance to shape the future of how we support Commercial Research in Primary Care
Basics of Commercial Research
Basics of Commercial Research
If you are starting your commercial portfolio, need a refresher or want to learn more, below you can find a modular bitesize series where we discuss different aspects of the lifecycle of a commercial study.
A group of commercially active and commercially curious practices meet every 2 months on a Tuesday lunch time 1pm-2pm. Here we discuss national updates, share experiences and look in depth at new and upcoming studies. To join this group, please email em.rrdn@nihr.ac.uk >, or click here to add the meeting to your calendar. To see previous presentations, agendas and minutes please find them here.
- What is commercial research?
The first meeting of the series, we will introduce commercial research, how it differs from non-commercial research and showcase the benefits of delivering a commercial study. We will also talk what it involves and the different types of commercial studies.
2. Life-cycle of a commercial study
2. Life-cycle of a commercial study
In this meeting, we will discuss and overview of the life-cycle of a commercial study. A step by step guide on what delivering a commercial study entails, from feasibility to study closedown.
3. Finding a study for your practice
3. Finding a study for your practice
In this meeting we will discuss how to identify a suitable study for your practice and patient population, how to submit a good expression of interest and site ID form, and general tips to increase the chances of being selected for a commercial study. Please note, if you have recently attended the "Commercial feasibility workshop" in NIHR Learn, this session will be very similar.
4. Study set up preparation
4. Study set up preparation
The fourth meeting in the series, we will discuss all documents and actions you need to do before opening a commercial study. Having templates and documents set up from the start will help with efficient communication with the study team, patients and help answer any questions the sponsor or clinical research organisation may have.
5. Clinical Research Organisations (CROs)
5. Clinical Research Organisations (CROs)
What is a Clinical Research Organisation? What is the difference between a CRO and a sponsor? In this meeting we will learn about CROs, their structure , roles and responsibilities and terminology commonly used.
6. Contracts
6. Contracts
In the sixth meeting of the series, we will be discussing commercial contracts. These can be found on the HRA websites and include the financial appendix with instructions on who to contact. We will also discuss financial tracking and how it differs from non-commercial studies. Please note, specific studies and financial situations cannot be discussed in this webinar. Please speak to the CRN EM for any specific questions and concerns.
7. Capacity and Capability
7. Capacity and Capability
What is capacity and capability and the green light process? In the seventh meeting of this series we will discuss what this process entails and how to get there, including Site Qualification Visits (SQV), Site Initiation Visits (SIV) and issuing C&C.
8. NCVR
8. NCVR
We will learn about:
1. Understanding NCVR
2. Escalation process
9. All things Admin
9. All things Admin
We will learn about:
Source data
Investigator Site Files (ISFs)
Monitoring visits
Case report form (CRFs)
10. Recruitment
10. Recruitment
We will learn about:
Pre-screening patients
Timings needed for a commercial study
Have contingency plans
Team communication
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