What is Research Delivery?
Research Delivery is the process of carrying out all study activities in accordance with the study protocol and agreed local Standards of Practice (SOPs).
Effective research delivery ensures that studies are conducted safely, ethically and consistently while maintaining compliance with governance requirements and Good Clinical Practice standards.
Research Staff Responsibilities
Successful research delivery relies on clearly defined responsibilities and accountability throughout the study lifecycle.
Chief Investigator (CI)
Holds overall responsibility for the study at Sponsor level and works closely with the Principal Investigator throughout the life of the project.
Principal Investigator (PI)
- Organises and signs the delegation log.
- Ensures all study staff are appropriately trained.
- Implements study amendments.
- Maintains the Site File, Screening Log and Source Data Forms.
- Reports Adverse Events (AE).
- Maintains version control and document management.
- Ensures secure transfer of research data.
- Appropriately delegates study activities.
- Confirms participant eligibility.
- Ensures recruitment targets are achieved.
Research Staff
- Work within the study protocol and local SOP guidance.
- Follow Good Clinical Practice (GCP) standards.
- Maintain secure handling of research data.
What is Research Delivery?
Research delivery means carrying out study activities in accordance with the study protocol and agreed local Standard Operating Procedures.
Effective delivery supports participant safety, reliable data and compliance with Good Clinical Practice and research governance requirements.
What You Will Learn
This section explains research roles, participant processes, study management and the practical requirements for delivering research.
Research Roles
Understand the responsibilities of investigators and research staff.
Participant Journey
Understand screening, consent, recruitment and follow-up.
Study Management
Maintain study records, amendments, data and governance documentation.
Study Close-down
Complete reconciliation, closure and archiving requirements.
Research Staff Responsibilities
Clear roles and appropriate delegation support safe and effective study delivery.
Chief Investigator
Holds overall responsibility for the study at Sponsor level and works with the Principal Investigator.
Principal Investigator
- Maintains the delegation log.
- Confirms training and eligibility.
- Oversees recruitment and amendments.
- Maintains study files and logs.
- Reports Adverse Events.
- Controls documents and data transfer.
Research Staff
- Work within the protocol and local procedures.
- Follow Good Clinical Practice.
- Protect research data.
Research Delivery Pathway
Depending on the role, research staff may not be involved in every stage.
- Advertising: promote the study using approved communications.
- Screening: identify eligible participants and maintain the Screening Log.
- Consent to Contact: obtain permission for the study team to make contact.
- Consent: provide clear information and obtain documented informed consent.
- Recruitment: enrol eligible participants and monitor targets.
- Randomisation: allocate participants as defined in the protocol.
- Data Collection: record, transfer and store study data securely.
- Study Management: maintain amendments, logs, documents and participant arrangements.
- Baseline Appointment: complete initial assessments and consent where applicable.
- Follow Up: complete scheduled reviews and ongoing data collection.
- Close-down and Archiving: reconcile records, close the site and archive securely.
Before Delivery Begins
- Identify responsibility for each study activity.
- Record all authorised staff on the Delegation Log.
- Confirm whether additional resources are required.
- Develop local SOPs where the protocol needs BCHC-specific detail.
- Discuss local procedures with the Sponsor and R&I Team.
Planning Considerations
Permissions and Access
Medical records, databases, platforms and electronic Site Files.
Funding and Incentives
Sponsor funding, R&I support, costs and participant reimbursements.
External Services
Pharmacy, laboratory, couriers, bank staff and additional study staff.
Staff
Delegation, RiO access, DBS requirements and investigator records.
https://www.hra.nhs.uk/planning-and-improving-research/best-practice/investigators-cv/ View investigator CV guidanceTraining
GCP, study-specific skills, clinical training and data handling.
https://bchceducation.co.uk/ Visit BCHC EducationParticipant Feedback
Use approved methods to capture the participant research experience.
https://www.nihr.ac.uk/documents/participant-in-research-experience-survey-pres-202122/31768 View PRES informationData and Samples
Secure transfer, restricted storage, couriers and laboratory requirements.
Communication
Email accounts, mailing lists, meetings, newsletters and dissemination.
Equipment and Venue
Clinical equipment, IT, storage, clinic space and waste disposal.
Site File Management
Keep paper or electronic Site Files current, secure and accessible only to authorised staff. Localise study documents for BCHC where required.
Support and Guidance
The BCHC Research & Innovation Team can support Principal Investigators with research delivery, local processes and study set-up.
Download the Research Delivery Crib Sheet
Use the crib sheet as a quick reference guide for planning and delivering research.