Standard Operating Procedure
SOP number:
SOP-JRO-20-002
SOP full title:
SOP effective:
Regulatory Green Light Process for Clinical Trials of
Investigational Medicinal Products
06 May 2016
Review date:
06 May 2018
SOP author signature:
SIGNED COPY HELD WITHIN THE NJRO
Ms Vicky Stevenson, Quality Assurance Manager
SOP approval signature:
SIGNED COPY HELD WITHIN THE NJRO
Ms Susan Ridge, Research Governance Manager
SOP HISTORY
Version
001
Date
23 December 2013
Reason for change
Biennial review
1. BACKGROUND/INTRODUCTION
Prior to authorising the start of a clinical trial and the initiation of research sites, the
sponsor must ensure that all approvals, contracts and necessary documentation are in
place. Records must be available to verify that all required documents have been
received and checked by the sponsor and once these are ready, the trial can
commence. This process is referred to as the ‘regulatory green light’.
2. PURPOSE
This Standard Operating Procedure (SOP) describes the regulatory green light process
for Clinical Trials of Investigational Medicinal Products (CTIMPs) where The Newcastle
upon Tyne Hospitals NHS Foundation Trust (NUTH FT) is acting as research sponsor. It
does not describe the processes for technical release or regulatory release of
Investigational Medicinal Products (IMPs) by a Qualified Person.
SOP Template Version 1.1, 12-2-12
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This document is designed for on-line viewing.
Printed copies, although permitted, are deemed Uncontrolled 7days after the date above
NOTE: Due to the phased introduction of the Health Research Authority (HRA)
Assessment & Approval during 2015/16 some research approval processes will be
affected. Some of the processes in the following SOP will be subject to minor changes
which will be communicated to staff as and when required. SOPs will be revised at the
end of the HRA implementation period to reflect these changes but until then
researchers are ask to consult the NJRO and website for the most up to date information
on changing procedures.
3. SCOPE
The SOP is applicable to Chief Investigators (CI) and delegated trial team members
involved in NUTH FT-sponsored CTIMPs. Where responsibility for performing the
regulatory green light procedure is delegated to a Clinical Trials Unit (CTU), this SOP is
also applicable to the assigned Trial Manager.
The SOP is also applicable to the Research Governance Manager (RGM), Research
Management & Governance (RM&G) Managers and Quality Assurance Manager with
responsibility for performing sponsor activities on behalf of NUTH FT.
4. PROCEDURE
4.1. Responsibilities
For those trials not managed by a CTU the responsibility for performing the
regulatory green light process is delegated to the CI (or delegate).
For those trials where a CTU is employed to manage the trial, the responsibility for
performing the regulatory green light process will be delegated to the assigned Trial
Manager.
4.2. Process for Single Site Trials
For single site trials not managed by a CTU, the CI will go through the clinical trial
regulatory green light checklist to ensure that all approvals and necessary
documentation are in place. Once the checklist is complete it must be signed and
dated by the CI. An electronic copy must be forwarded to a RM&G Manager or the
RGM with the original filed in the Trial Master File (TMF).
If the regulatory green light process is completed by a CTU, a copy of the
documentation used to record the process must be forwarded and receipt
acknowledged in writing by NUTH FT sponsor team prior to the start of the trial.
4.3. Process for Multi-Site Trials
For multi-site trials a two-stage process will be used to confirm:
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 all national approvals and documents are in place prior to the trial
commencing
 all local approvals and documents are ready prior to the opening of an
individual research site
4.3.1. Trial Regulatory Green Light Process
For those trials without the involvement of a CTU, the CI (or delegate) will
complete the study start up and regulatory green light checklist and forward
a hard copy to the NUTH FT sponsor team. Upon receipt, an RM&G
Manager or the RGM will review the checklist ensuring all required actions
have been completed. If there are any items outstanding, the CI (or
delegate) will be informed and have to rectify any issues prior to
resubmitting the checklist to the RM&G Manager or the RGM. Once ready,
the RM&G Manager or RGM will countersign the checklist on behalf of NUTH
FT and return the original to the CI, retaining an electronic copy within R&D.
Where a CTU is responsible for the trial, the documentation used to record
the process must be forwarded and receipt acknowledged in writing by the
NUTH FT sponsor team.
4.3.2. Site Green Light Process
For each site involved in a multi-centre trial, the CI (or delegate) must
complete a site regulatory green light checklist and forward a copy of the
completed form to NUTH FT sponsor team . Upon receipt the checklist will
be reviewed by a RM&G Manager or the RGM before acknowledging receipt.
Where a CTU is responsible for the trial, the documentation used to record
this process must be forwarded and receipt acknowledged in writing by the
NUTH FT sponsor team.
5. REVIEW AND MONITORING OF THIS DOCUMENT
This SOP will be reviewed every 2 years or in the event of a change to the appropriate
regulations. Trust R&D will monitor the use of this SOP for its sponsored trials.
6. REFERENCES
6.1. MHRA Good Clinical Practice Guide, 2012 - https://www.gov.uk/guidance/goodclinical-practice-for-clinical-trials
6.2. NJRO website/SOP Related Documents: Study Start Up & Regulatory Green Light
Checklist - http://www.newcastlejro.org.uk/research-governance/standardoperating-procedures/jro-sops/
7. APPENDICES
Not Applicable
SOP Template Version 1.1, 12-2-12
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SOP-JRO-20-002
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This document is designed for on-line viewing.
Printed copies, although permitted, are deemed Uncontrolled 7days after the date above