Title: Definition of Responsibilities
SOP Number and Version: 2, V1
Effective Date: 26/09/2014
Review Date: 26/09/2017
Please check this is the latest version of the SOP on the Joint Research Office
website: www.ucl.ac.uk/jro.
Author:
Name: Shivali Trivedi
Position: IT/Portfolio Coordinator & QA Manager (Cancer Clinical Trials Unit)
___________________________________
Signature
Date
Approved by:
Name: Suzanne Binks
Position: Quality Assurance Coordinator
____________________________________
Signature
Date
Authorised by:
Name: Rajinder Sidhu
Position: Deputy Director of Research Support Centre
_______________________________________
Signature
Date
Definition of Responsibilities, SOP 2, V1, 15/09/2014
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Revision Chronology:
Version Effective
Number: date:
1
Reason for change:
26/09/2014 First version includes UCLH standardisation.
ACRONYMS
Co-I
CTA
CTP
DM
GCP
ICH
IMP
LRN
PI
QA
R&D
RN
SOPs
SSI
Author:
Shivali
Trivedi
Co-Investigator
Clinical Trials Assistant
Clinical Trials Practitioner
Data Manager
Good Clinical Practice
International Conference on Harmonisation
Investigational Medicinal Products
Lead Research Nurse
Principal Investigator
Quality Assurance
Research and Development
Research Nurse
Standard Operating Procedure
Site Specific Information
BACKGROUND
At the participating site, the PI is responsible for the conduct of the clinical trial to ensure the safety of
participants and the reliability and robustness of the data generated. The PI as leader of the research
team may delegate his/her duties. The site delegation log is an essential clinical trial document to
record the responsibilities of the research team authorised by the PI. It is used as evidence to
demonstrate how individuals are assigned tasks appropriate to their education, training and
experience.
The SSI form section 23 includes the PI declaration as part of the NHS permission (R&D approval)
process. By providing an e-authorisation for the declaration, the PI agrees to abide by the
responsibilities stated. (Appendix 3)
PURPOSE
To ensure that members of the research team understand the importance of the allocation of
responsibilities and to clarify boundaries of responsibility for the effective management and conduct of
the clinical trial.
PROCEDURE
Who?
The study staff members involved in clinical trials include, but are not limited to, the following:
 Principal Investigator (PI)
 Co-Investigators (Co-I)
Definition of Responsibilities, SOP 2, V1, 15/09/2014
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Specialist Registrars (SpR)
Lead Research Nurse (LRN)
Research Nurse (RN)
Clinical Trials Practitioner (CTP)
Data Manager (DM)
Clinical Trials Administrator (CTA)
Additional Study Staff: Clinicians, Specialist Nurses, Pharmacists, Laboratory staff, Other
support staff (e.g. Radiology)
Actions (When? How?)
Responsible
persons
(Who?)
Responsibilities of the Principal Investigator (PI)
PI
The PI is ultimately responsible for all trial activity at the trial site.
The PI should maintain a list of appropriately qualified persons to whom they
have delegated significant trial-related duties and ensure that all persons
assisting with the trial are appropriately qualified, experienced and adequately
informed about the protocol, their trial-related duties, and the IMPs.
2
Study Delegation Log
PI
The PI must keep a record of the delegation of clinical trial duties as per the
Sponsor’s requirements through a Delegation Log (see template in Appendix
1).
The PI may delegate duties to key study staff as outlined in Appendix 2.
3
Signing the Delegation Log
Study staff
Key study staff members are responsible for signing the study Delegation Log
prior to working on the study to confirm that they are delegated tasks
appropriately.
The PI should countersign the delegation log prior to an individual commencing
any trial related activity.
4
Additional Staff
Additional
study staff
Where applicable additional staff associated with, but not directly involved in
the research trial should also take responsibility for signing the study
Delegation Log to confirm that they have delegated tasks appropriately.
The PI should countersign the delegation log prior to an individual commencing
any trial related activity.
Definition of Responsibilities, SOP 2, V1, 15/09/2014
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Evidence of Qualification and Training
Delegated
individual
A delegated individual (e.g. Data Manager) may be assigned the responsibility
of ensuring the study Delegation Log is kept updated with staff changes and
maintain records of training with current study staff CVs & GCP Certificates (as
further evidence of qualifications & training).
6
Pre-Study Phase
Study staff
During the pre-study phase, the PI & delegated study staff responsible for the
clinical trial should discuss and agree on the study requirements (and with the
Sponsor, if appropriate), ensuring all necessary procedures and assessments
are understood. All protocol requirements will be identified and delegation of
responsibilities agreed prior to commencing recruitment.
Individual trial related duties should be defined, established, agreed and Study staff
recorded on the study Delegation Log.
As new staff members join the study team, trial related duties and functions Study Staff
should be defined, established, agreed and allocated prior to the individual
commencing work on the study.
During the R&D trial submission process, the PI acknowledges their study PI
responsibilities by signing the declaration on the trial’s SSI form.
Research Units at UCLH may also ensure their study PIs sign other documents
to allow oversight over their respective trials (e.g. The Cancer Clinical Trials
Unit (CCTU) requires that their study PIs read and sign a ‘PI Responsibilities
Agreement Form’ and re-sign every 2-years. This form serves as a reminder of
PI duties and responsibilities – it is not trial specific and is stored centrally with
the CCTU CTA).
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Open Study Phase
PI
During the open-study phase, the PI is responsible for the medical care and
supervision of patients on trial, as well as the overall responsibility for the study
at the site.
The PI & delegated study staff responsible for the clinical trial should ensure Study staff
they are observing the study protocol requirements (e.g. Informed consent,
timely SAE reporting) and adhering to their individual responsibilities, as
defined on the study delegation log.
Any new staff members working on the trial are responsible for signing the Study staff
study Delegation Log prior to working on the study to confirm that they are
delegated tasks appropriately.
The PI should countersign the delegation log prior to an individual commencing PI
any trial related activity.
Definition of Responsibilities, SOP 2, V1, 15/09/2014
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Study Closure Phase
PI
During the study closure phase, the PI has overall responsibility for the study at
the site.
The PI & delegated study staff responsible for the clinical trial should ensure Study staff
they are observing the study closure requirements as per the study protocol &
UCLH Study Closure SOP and adhering to their individual responsibilities, as
defined on the study delegation log.
Any new staff members working on the trial are responsible for signing the Study staff
study Delegation Log prior to working on the study to confirm that they are
delegated tasks appropriately.
The PI should countersign the delegation log prior to an individual commencing PI
any trial related activity.
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Post-Study Closure Phase
PI
During the post-study closure phase, the PI has overall responsibility for the
study at the site.
During the post-study closure phase, the PI & delegated study staff responsible Study staff
for the clinical trial should ensure they are following the study protocol & UCLH
Archiving SOP and adhering to their individual responsibilities, as defined on
the study delegation log.
Any new staff members working on the trial are responsible for signing the Study staff
study Delegation Log prior to working on the study to confirm that they are
delegated tasks appropriately.
The PI should countersign the delegation log prior to an individual commencing PI
any trial related activity.
REFERENCES
ICH GCP E6(R1)
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1
__Guideline.pdf
Research Governance Framework for Health and Social Care 2005 (2nd Edition)
UCLH SOP9: Study Close Down
UCLH SOP10: Archiving of Investigator Site File & Pharmacy Site File (if applicable)
APPENDICES
Appendix 1 – Template: Delegation Log
Appendix 2 – Responsibilities of Site Staff
Definition of Responsibilities, SOP 2, V1, 15/09/2014
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APPENDIX 1: STUDY DELEGATION LOG
Protocol Title/name:
Principal Investigator:
Name
Protocol No:
Site/site no:
Initials
Job Description
Signature
Responsibilities
Date started
work on Trial
Date finished
on Trial
Authorised by PI & Date
* Key:
1 – Overall responsibility for study at site
2 – Ethics
3 – Screening of patients
4 – Randomisation
5 – Obtaining Informed Consent
6 – Patient’s assessments & medical care
7 – Prescriptions
8 – Administration of investigational product
9 – Reporting of Adverse Events & Serious Adverse Events
10 – CRF completion & data queries
11 – Maintain essential documents & study site file
12 – Drug receipt, dispensing & accountability
Definition of Responsibilities, SOP 2, V1, 15/09/2014
13 – Maintain Pharmacy File
14 – Storage of investigational product
15 – Monitoring visit support
16 – Archiving
17 – Other (specify):
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APPENDIX 2: APPROVED RESPONSIBILITIES OF SITE STAFF
The list below is to serve as a guide of approved trial responsibilities for study staff members.
Please note: Additional responsibilities (not listed in each category) may be delegated if staff are appropriately qualified, trained and authorised on the study delegation log by the PI.
Co-Investigator (including
Consultants & Clinicians in training)
Chief/Principal Investigator
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Overall responsibility for study at site
Medical care and supervision of patients
Delegation of study related duties appropriately
Ensure all staff delegated to work on trial are:
o
Qualified by education, training &
experience
o
Thoroughly familiar with study protocol
and the investigational product(s)
o
Aware of, and compliant with GCP and
any applicable regulatory requirements
pertaining to clinical trial conduct
o
Aware of relevant SOPs
Familiarity with Investigator Brochure
Recruitment Strategy
Screening
Informed Consent
Completion of Informed Consent Form
Randomisation
Administration of study drug
Collection of trial related blood samples
Completion and return of CRF’s and providing
responses to data queries – overall trial data
oversight
Prescriptions
Documentation of Adverse Events (AE) and
signing AE forms
Timely Serious Adverse Events (SAE) Reporting
and signing of SAE forms
Initiation of new trial personnel
Ethics committee approval/communications re:
amendments
Negotiation and completion of the financial
agreement
Indemnity, compensation and insurance
Investigational product accountability and
monitoring of compliance
Available for audit and inspections
Archiving
Others, as locally applicable
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Screening of patients for eligibility
Medical care of patients
Informed consent
Completion of Informed Consent
Form
Randomisation
Prescriptions
Administration of study drug
Responsible for collection of trial
specific blood samples
Completion and return of CRF’s
and providing responses to data
queries
Documentation of Adverse Events
(AE) and signing AE forms
Timely Serious Adverse Events
(SAE) Reporting and signing of
SAE forms
Ethics committee obligations
Available for audit and inspections
Archiving
Others, as locally applicable
Research Nurse (RN) &
Clinical Trials Practitioner (CTP)
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Screening of patients for eligibility
Informed Consent (information
giving only, unless protocol and
necessary regulatory authority
permits the RN or CTP to obtaining
written informed consent)
Randomisation
Administration of study drug
Responsible for collection of trial
specific blood samples
Documentation of Adverse Events
in source data
Completion and return of CRF’s
and data queries
Support monitoring visits, audits
and inspections
Preparation of SAE reports for
medical input and causality
assessment
Notifying patient’s GP of their
involvement in the study
Organisation of clinic appointments
and investigations as per protocol
requirements
Ensuring that the patient is aware
of who to contact should they
experience problems or side effects
between clinic visits
As appropriate, collect study IMP
from pharmacy and provide to
patient
Others, as locally applicable
Definition of Responsibilities, SOP 2, V1, 15/09/2014
Data Manager
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Screening of patients for eligibility
Randomisation
Informed Consent (only if
delegated this responsibility by
study PI as per Informed Consent
SOP)
Data entry
Completion and return of CRF’s
and data queries
Support monitoring visits, audits
and inspections
Preparation of SAE reports for
medical input and causality
assessment
Investigator/Study site file set up
and maintenance
Maintenance of trial logs and
essential documents
Preparations of paperwork for
Ethics committee/R&D
General Assistance with coordination of trial follow-up
procedures
Shipment of trial related samples
Archiving
Others, as locally applicable
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Pharmacist
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Acknowledge receipt of
trial supplies
Drug accountability and
monitoring of compliance
Dispensing of
investigational product to
patients
Complete dispensing log
Maintain Pharmacy Site
File
Monitor storage of
Investigational Product
Others, as locally
applicable
Appendix 3 – SSI Section 23 Principal Investigator Declaration
Please note: The current declaration form will be found on IRAS when authorising a trial SSI form.
23. Authorisations required prior to R&D approval
The local research team are responsible for contacting the local NHS R&D office about the research project. Where the
research project is proposed to be coordinated centrally and therefore there is no local research team, it is the responsibility
of the central research team to instigate this contact with local R&D. NHS R&D offices can offer advice and support on the
setup of a research project at their organisation, including information on local arrangements for support services relevant to
the project. These support services may include clinical supervisors, line managers, service managers, support department
managers, pharmacy, data protection officers or finance managers depending on the nature of the research. Obtaining the
necessary support service authorisations is not a prerequisite to submission of an application for NHS research permission,
but all appropriate authorisations must be in place before NHS research permission will be granted. Processes for obtaining
authorisations will be subject to local arrangements, but the minimum expectation is that the local R&D office has been
contacted to notify it of the proposed research project and to discuss the project’s needs prior to submission of the
application for NHS research permission via IRAS. Failure to engage with local NHS R&D offices prior to submission may
lead to unnecessary delays in the process of this application for NHS research permissions.
Declaration:
I confirm that the relevant NHS organisation R&D office has been contacted to discuss the needs of the project and
local arrangements for support services. I understand that failure to engage with the local NHS R&D office before
submission of this application may result in unnecessary delays in obtaining NHS research permission for this
project.
Declaration by Principal Investigator or Local Collaborator
1. The information in this form is accurate to the best of my knowledge and I take full responsibility for it.
2. I undertake to abide by the ethical principles underpinning the World Medical Association's Declaration of Helsinki
and relevant good practice guidelines in the conduct of research.
3. If the research is approved by the main REC and NHS organisation, I undertake to adhere to the study protocol, the
terms of the application of which the main REC has given a favourable opinion and the conditions requested by the
NHS organisation, and to inform the NHS organisation within local timelines of any subsequent amendments to the
protocol.
4. If the research is approved, I undertake to abide by the principles of the Research Governance Framework for Health
and Social Care.
5. I am aware of my responsibility to be up to date and comply with the requirements of the law and relevant guidelines
relating to the conduct of research.
6. I undertake to disclose any conflicts of interest that may arise during the course of this research, and take
responsibility for ensuring that all staff involved in the research are aware of their responsibilities to disclose conflicts
of interest.
7. I understand and agree that study files, documents, research records and data may be subject to inspection by the
NHS organisation, the sponsor or an independent body for monitoring, audit and inspection purposes.
8. I take responsibility for ensuring that staff involved in the research at this site hold appropriate contracts for the
duration of the research, are familiar with the Research Governance Framework, the NHS organisation's Data
Protection Policy and all other relevant policies and guidelines, and are appropriately trained and experienced.
9. I undertake to complete any progress and/or final reports as requested by the NHS organisation and understand that
continuation of permission to conduct research within the NHS organisation is dependent on satisfactory completion
of such reports.
10. I undertake to maintain a project file for this research in accordance with the NHS organisation's policy.
11. I take responsibility for ensuring that all serious adverse events are handled within the NHS organisation's policy for
reporting and handling of adverse events.
12. I understand that information relating to this research, including the contact details on this application, will be held by
the R&D office and may be held on national research information systems, and that this will be managed according to
the principles established in the Data Protection Act 1998.
13. I understand that the information contained in this application, any supporting documentation and all correspondence
with the R&D office and/or the REC system relating to the application will be subject to the provisions of the Freedom
of Information Acts and may be disclosed in response to requests made under the Acts except where statutory
exemptions apply.
Definition of Responsibilities, SOP 2, V1, 15/09/2014
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