Sponsor Delegated Roles and Responsibilities Matrix

Use to document the individual roles of sponsor and CI in delivery of PHT Sponsored studies.

STUDY TITLE:
CHIEF INVESTIGATOR / LEAD DEPT:
REF NUMBERS / EUDRACT: / OTHER / REC:
TASK CATEGORY / TASK / INTERNAL
at PHT / EXTERNAL ORG:
Name & lead contact
STUDY SET-UP
STUDY PREPARATION & DEVELOPMENT / Undertake the role of Sponsor as defined by the Medicines for Human Use Regulations 2004, as amended / PHT
Ensure appropriate insurance or indemnity arrangements are in place to cover liabilities / R&D
Employ/Is Responsible for the Chief Investigator / PHT
Establish Core Study Team / CI
Ensure suitability of the core Research Team & Project Management Systems / R&D / CI
Employs/Is Responsible for Collaborators on the Project Team (incl. Supervisors) / CI
Establish status of study – CTIMP/medical device/interventional etc as defined by IRAS / CI with R&D
Leads Writing of Grant Application / CI
Provides advice of study costings / R&D
Secure funding for the study / CI
Administering the Project Funds/Grant / R&D
Allocating NHS Support Funding / R&D
Writes Protocol and related patient documentation (PIS, consent form etc) and trial specific instructions / CI
Creates CRFs & study logs / CI / CTU
Creates study database / CI / CTU
Contributing to Protocol Development and related documents / R&D / CTU
Provide statistical support
Write statistical plan
Arrange Peer Review/Quality Assessment / CI
Ensure External Peer Review/Quality Assessment. / R&D
Contract Management – draft, negotiate and manage with sites and subcontractors / R&D
Establishing & Reporting on the Activities of the following, (where appropriate):
  • The Project Steering Committee
  • The Project Data Safety Monitoring Committee
  • The Project Management Committee
/ CI
Complete Study Risk Assessment / R&D with CI / CTU
Write monitoring plan / R&D with CI / CTU
Approve monitoring plan / R&D / RQC
Prepare and maintain Trial Master File / CI with R&D
Prepare and maintain investigator site files for participating sites / PI with R&D / CTU –TM
Provide TMF SOP and relevant documentation to assure compliance / R&D
Populating, signing and maintaining Delegation Log / CI / PI at participating sites
STUDY APPLICATIONS & REGISTRATIONS / Completes Application form for Trust sponsorship / CI
Apply for sponsorship / CI
Apply for Clinical Trial Authorisation (MHRA) / CI
Apply for Ethical Opinion / CI
Apply for portfolio adoption / CI
Apply for NHS Permission at lead site / CI
Identify, recruit and liaise with participating sites / CI / CTU- TM
Apply for NHS Permissions at Participating Sites / PI / CTU- TM
Register Trial on EUDRACT and ISRCTN / CI
Prepare Quarterly Progress Reports to the Sponsor / CI / CTU- TM
Reviewquarterly reports and take necessary action / R&D/RQC/TSC/
TMG/DMC as appropriate
STUDY & SITE INITATION / Liaise with all involved support departments to ensure readiness at CI and Participating sites / CI / PI at participating sites
Arrange Site Initiation at the lead site / CI
Arrange Site Initiation at participating sites / PI / CTU- TM
Ensure Study Initiation Checklist is completed before permission to proceed to recruitment / R&D
Provide IMP control & accountability procedures / Pharmacy
Re-train study team in revised protocol & study specific procedures / CI
Ensure GCP training of all Research Staff recruiting to study / CI / PI at participating sites
Re-train study team in SOPs and new TMF documents / R&D
Issue final study permission letter to proceed to recruitment / R&D
STUDY CONDUCT
GENERAL CONDUCT & COMPLIANCE / Ensure that no participant is recruited until favourable ethics, MHRA and R&D approvals are in place / CI / PI at participating sites
Ensure the study is conducted in accordance with the approved protocol and study documentation, Trust SOPs and GCP / CI / PI at participating sites
Ensure the rights of the individual patients are protected at all times and that they receive appropriate medical care / CI / PI at participating sites
Ensure the safety of participants and quality of data throughout the study / CI / PI at participating sites
Ensure all participants have given freely informed consent and that this is conducted and recorded in accordance with the Trust’s written procedures / CI / PI at participating sites
Ensure all study participants are clearly identified in the notes by a study sticker to be placed on the inside front cover of the notes / CI / PI at participating sites
Maintain the Trial Master File securely for the duration of the study / CI
Notify the Research Office of any change in TMF location and ensure its availability upon request for monitoring and audit purposes / CI
Maintain a record of TMF location at all times / R&D
Ensure the appropriate onward delegation of all tasks and record them on the delegation log in the TMF / CI
Maintain up-to-date SOP and GCP training / CI / PI at participating sites
Provide additional SOP training upon request / R&D
Retain responsibility for Randomisation Procedures / CI / Pharmacy / CTU
Maintain the study blind at all times unless emergency or safety procedures apply / CI / PI at participating sites
Establish a Trial Management Committee and hold regular meetings to oversee the conduct and progress of the study / CI
Prepare and submit annual progress reports to the Research Office and the REC / CI / CTU –TM
Review progress reports and oversee changes and submission to the REC / R&D
SAFETY / Ensure an SAE Alert Notices is added to all versions of the participants notes / CI / PI at participating sites
Assess all adverse events in accordance with PHT/RDSOP/007 and the study protocol. / CI / PI at participating sites
Report all “reportable” adverse events on PHT AE 1 Form and submit to the research office for entering into the study safety database / CI / PI at participating sites
Report all SAEs, SSARS and SUSARs to the Research Office immediately, in accordance with the R&D SOP on Adverse Event Reporting PHT/RDSOP/007 / CI / PI at participating sites
Review adverse event data for trends that collectively may indicate a Serious Adverse Event or Reaction / CI / RQC / CTU- Phamacovigilence
Manage reported SAEs, SSARS and SUSARS in accordance with PHT/RDSOP/007 and R&D Office SAE tracker 5 / R&D
Expedite all SUSARs to the MHRA and REC within the appropriate time frame / R&D
Record and notify Sponsor of all pregnancy-related adverse events, including outcome of pregnancy / CI / PI at participating sites
Report Breach to sponsor / All staff
Review reported breaches for seriousness in line with Trust procedures and activate the serious breach tracker / R&D
Notify MHRA of Serious Breach / R&D
Implement Urgent Safety Measures where appropriate and notify the Research Office, MHRA and REC within 3 days in line with Trust procedures PHT/RDSOP/006 / CI / PI at participating sites
Notify the Research Office immediately of a temporary halt due to safety / CI
Notify the MHRA and REC of a temporary halt due to safety / R&D
Prepare Annual Drug Safety Update Reports (DSURs) to the Research Office by the agreed date and in accordance with PHT/RDSOP/007 / CI
Annual update of Investigator’s Brochure (IB) / CI
Undertake an annual check on status of SmPC and ensure the prompt implementation of any changes to study procedures and documentation / CI
Oversee SmPC updates and changes via the DSUR review process. Review, approve and submit DSURS to the MHRA by the agreed date and in accordance with PHT/RDSOP/007 / R&D
DATA MANAGEMENT / Maintain and control access to the study database / CI / CTU
Ensure any research data held on a study database is kept securely on a shared PHT drive and that this location and password are provided to the research office / CI / CTU
Record and keep secure the location of data and the password for access / R&D
Data entry
Uploading of recruitment data on to the NIHR portfolio / CTU
Uploading of recruitment data on to EDGE
Ensure data quality / CI
Raise & chase data queries / CTU- TM
Report suspected research misconduct to the sponsor / CI
Review of suspected misconduct and taking appropriate reaction / R&D
Co-ordination of the Data Monitoring Committee
Carrying out interim analysis
IMP / Ensure IMP is provided and labelled in accordance with the Medicines for Human Use (Clinical Trials) regulations 2004 / CI / Pharmacy
Ensure that accurate records are kept relating to storage, dispensing, movement, delivery and destruction/return of IMP as applicable / Pharmacy
Ensure that IMP is appropriately stored in secure conditions / Pharmacy
Ensure the control and accountability of IMP and Placebo / CI / Pharmacy
Ensure preparation of the IMP and Placebo is in accordance with the Trial Specific Procedure for study medication preparation / CI / Pharmacy
Responsibility for Code Break Procedures / Pharmacy / CTU
DEVICES / Obtain letter of No Objection from MHRA for use of Device for new purpose / CI
Ensure that sufficient product is available for the planned number of participants / CI
Ensure that investigational medicinal devices are not used for any purpose other than those described in the protocol / CI / PI at participating sites
Ensure records are kept relating to storage, movement, return to manufacturer and destruction of medical devices / CI
Ensure appropriate secure storage of medical devices / CI
TISSUE USAGE & STORAGE / Ensure the collection, usage and storage of tissue is in accordance to HTA / CI
AMENDMENTS / Identify any need for amendments to be made to the protocol or associated documents / CI
Determine whether proposed amendments are “minor” or “substantial” and authorise all amendments / R&D
Update documents affected by amendment / CI
Ensure version control is consistent and correct / CI
Prepare submissions to MHRA & Ethics Committee & obtain approval / CI
Notify all other staff/sites about amendments, including updates to IB and SmPC / CI
MONITORING / Arrange and conduct monitoring / R&D / CTU
Comply with all monitoring visits and ensure all findings are addressed appropriately / CI / PI at participating sites
Complete Good Clinical Practice tool as required by the Research Office / CI / PI at participating sites
Conduct oversight visits of ward based IMP and placebo, control and accountability procedures / Pharmacy
STUDY SPECIFC TASKS
END OF STUDY
CLOSE OUT / Notify and agree with the End of Trial as specified in the protocol / CI / R&D
Complete the End of Trial Notification Form and submit to the MHRA and Ethics committee. / CI
Ensure all documents and data queries are complete / CI / CTU- TM
Perform close down visits
Ensure validation of the final data before data lock / CI
Lock down the data base / CI
Ensure all essential documents are complete and filed in the TMF / CI
Ensure all adverse event data is included in the study analysis as appropriate / CI
Carrying out final analysis / CI
Write the end of study report and submit to the research office for approval before submission to the Ethics Committee. This must be within one year of the end of the study / CI
PUBLICATIONS / Prepare abstracts, posters and publications and submit to R&D Office for review / CI
Review dissemination materials prior to external submission for publication/use / R&D
External submission of abstracts, posters and publications / CI
ARCHIVING / Ensure all records are prepared for archive appropriately / CI
Ensure trial records and data are appropriately archived in accordance with Trust procedures / R&D

SIGNATURES

I can confirm that I have read and understood my roles and responsibilities as Chief Investigator for the above study and accept the tasks delegated to me by the Sponsor as outlined in the above matrix
Chief Investigator:
Chief Investigator Signature:
Date:
Sponsor Representative Name & Role
Sponsor Representative Signature:
Date:
CTU Representative Name & Role
CTU Representative Signature:
Date:

Sponsor Delegated Roles & Responsibilities Matrix, Version 1, 3/09/14

1