Integrated Research Application System (IRAS)
Site-specific assessment (SSA) for non-NHS sites
This document sets out general guidance on Site-Specific Assessment and
completion of the Site-Specific Information (SSI) Form for non-NHS sites. Separate
guidance is available within IRAS on the SSI Form for NHS sites.
Requirement for SSA at non-NHS sites

Site-specific assessment is an assessment of the suitability of the local research
site and investigator to conduct the research.

SSA for non-NHS sites is required as part of the ethical review for the following
types of research only:
(i)
(ii)
(iii)
(iv)
(v)
(vi)
Clinical trials of investigational medicinal products (CTIMPs)
Clinical investigations of non-CE marked medical devices or CE marked
devices which have been modified or are being used for a new intended
purpose
Combined CTIMPs and clinical investigations of medical devices
Other clinical trials to study a novel intervention or randomised clinical
trials comparing interventions in clinical practice
Intrusive research involving adults unable to consent for themselves in
England or Wales and requiring approval under the Mental Capacity Act
2005, and similar research in Northern Ireland
Research involving adults unable to consent for themselves and
requiring approval under the Adults with Incapacity (Scotland) Act 2000.

For other types of research taking place at non-NHS sites, application for SSA is
not required. All sites listed in the application to the REC, and any other sites
added during the course of the study, will be deemed to be ethically approved as
part of a favourable opinion from the REC. Management permission is still
required from the organisation responsible for hosting the research before it
commences at any site.

For detailed guidance on SSA procedures, see Section 4 of the NRES SOPs at
http://www.nres.npsa.nhs.uk/news-and-publications/publications/standardoperating-procedures.
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Identifying the research site

Research sites are organisations responsible for any participant-related research
procedures specified in the protocol - including recruitment and informed consent.

The following are not considered to be research sites:



Clinicians or clinical units making referrals to the research team.
Clinicians, clinical units or organisations involved only in the identification of
potential participants and/or facilitating recruitment by the research team, not
responsible for informed consent or any other protocol procedures
(“participant identification centres”)
Research units undertaking support functions, e.g. project management, site
monitoring, data analysis or report writing.

Whether a site is defined as NHS or non-NHS is not related to the physical
location of research activities, but to the organisation that is responsible for the
research activity.

In some cases, a study hosted by a NHS care organisation may involve routine
protocol procedures being undertaken by non-NHS organisations under
contractual arrangements with the NHS organisation. For example, MRI scans or
laboratory analysis may be undertaken on premises owned by universities,
research charities or private companies. These arrangements may be
considered as a single NHS site where all of the following conditions are met:
o
o
o
All the participants are NHS patients recruited through the NHS
organisation
The relevant NHS R&D office (which may be a joint research office acting
on behalf of more than one organisation) assumes full responsibility under
the Research Governance Framework for all procedures involving NHS
patients at the site, including those undertaken by non-NHS organisations
Indemnity for all procedures is in place under the Clinical Negligence
Scheme for Trusts (“NHS indemnity”).
Where any of these conditions are not met, the non-NHS organisation should be
considered a separate site.

For further guidance on research sites, see Section 4 of the NRES Standard
Operating Procedures http://www.nres.npsa.nhs.uk/news-andpublications/publications/standard-operating-procedures.
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SSA exemption for non-NHS sites
Non-clinical research involving adults lacking capacity to consent

The main REC has the discretion to waive the requirement for SSA at non-NHS
sites in the case of research involving adults lacking capacity to consent for
themselves where the study involves no clinical interventions and either of the
following apply:
(i)
Studies with no local investigator. All recruitment procedures and all
study procedures involving participants (e.g. questionnaires,
observations) are undertaken directly by the Chief Investigator’s team.
The role of local staff at the site is limited to facilitating the study, for
example by helping to identify potential participants and
relatives/consultees, who are then approached by the Chief Investigator’s
team.
(ii) Low risk studies. In this case, SSA may be waived where the main REC
is satisfied that the risk to participants lacking capacity is likely to be
negligible and will not interfere with their freedom of action or privacy in a
significant way or be unduly invasive or restrictive. These criteria could
apply for example to studies limited to use of personal data, or the
administration of a simple questionnaire involving minimal burden.

Before confirming SSA exemption, the main REC will require assurances that
the CI’s team will have adequate arrangements in place for the conduct of the
study locally, including procedures for identifying suitable sites, participants
and relatives/consultees. Where local site staff will be responsible for
undertaking recruitment or other study procedures, the main REC should be
satisfied that they will have appropriate training.

The CI or sponsor may submit a request for SSA exemption either with the
main application or in further correspondence at any time. However, the
Committee may decide to give exemption without receiving such a request.
Subsidiary sites in clinical research

In clinical research the main sites undertaking recruitment and administering
the interventions will always require SSA. However, it may be necessary to
arrange for routine clinical procedures required by the protocol to be carried
out by other organisations in support of the research. For example, routine
imaging using standard clinical protocols may be undertaken by a private
scanner centre under contractual arrangements with the NHS care
organisation where the participants are recruited. Unless the NHS
organisation accepts full governance responsibility for these procedures and
assures NHS indemnity, the responsible non-NHS organisation should be
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considered a separate research site or “subsidiary site”.

However, the Chief Investigator or sponsor may request exemption of nonNHS subsidiary sites from the requirement for SSA by writing to the main
REC giving the name and address of the subsidiary site, the name of the
person who will act as local Principal Investigator (i.e. take responsibility for
the conduct of study procedures) and brief details of the routine procedures to
be conducted.
Identifying the SSA REC

For non-NHS sites, applications for SSA should be submitted to an appropriate
Research Ethics Committee (“SSA REC”). This will normally be a local REC in
the domain where the site is located. For commercially sponsored Phase 1
trials, specific SSA RECs are assigned to undertake SSAs at each commercial
unit in the UK. For details of assigned SSA RECs for Phase 1 trials, see the
latest list on the NRES website, published at
http://www.nres.npsa.nhs.uk/applications/guidance/trials-and-procedureflowcharts/?entryid62=67028

The SSA may be undertaken by the main REC for the study itself where the site
is within its domain, or exceptionally for sites outside its domain where there is no
other suitable REC.

For further case-by-case advice on the appropriate REC to undertake SSA,
please contact the REC operational manager for the relevant area of the UK.
Applying for SSA

Application for SSA comprises the SSI Form together with the following:
o Short CV for the Principal Investigator
o Local versions on headed paper of all documentation to be used to recruit
participants at the site, including documentation for relatives/consultees in
the case of adults lacking capacity.
o MHRA accreditation certificate (where applicable - Phase 1 trial units only)
o Evidence of insurance or indemnity cover for the Principal Investigator
(except for commercial Phase 1 trial sites)
o Evidence of professional registration for the Principal Investigator.

The SSI Form should only be completed after the main study application form
(Parts A-D) has been completed by the Chief Investigator, as this will prepopulate some sections of the SSI Form. The CI will then forward the application
to the PI to complete the remaining questions in the SSI Form.
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
Where the SSA is to be undertaken by the main REC, the SSI Form should be
included with the main application for ethical review. Otherwise it should be
submitted separately to the appropriate SSA REC.
SSA process

Where the SSA is undertaken by the main REC, it will be undertaken as part of
the main review of the study. Where a favourable opinion is given, ethical
approval for the site will be confirmed in the main opinion letter.

Where SSA is the responsibility of another REC, it will be reviewed by a subcommittee of the SSA REC, normally in correspondence involving a minimum of
two members. The SSA REC will then notify the main REC, within 25 days of
receiving a valid application for SSA, whether or not it has any objection to the
research going ahead at the site.

On receiving the advice from the SSA REC, the main REC will confirm in writing
to the Chief Investigator whether or not the site is ethically approved. If notice of
no objection is received before the final opinion is given on the main application,
site approval will be included in the main opinion letter. If it is received
subsequently, a further letter will be issued.
General guidance on the SSI form

The Site-Specific Information (SSI) Form is an integrated form for use with both
NHS and non-NHS sites. The answer to the filter question will determine whether
the site is NHS or non-NHS and generate the appropriate dataset.

Where the applicant indicates that the SSA is to be undertaken by a REC other
than the main REC, a Summary of the Study will appear in the SSI Form,
populated from fields within Part A of IRAS. This provides the SSA REC with
background information about the study and avoids the need to provide a copy of
the main application form or protocol. The SSA REC will not re-review the
information submitted from Part A.

Where the answer to Question 4 indicates that the site is accredited by the
MHRA under its Phase 1 accreditation scheme, a number of subsequent
questions will be disabled, as they relate to issues routinely addressed by the
GCP inspectors within the accreditation process and do not need to be rereviewed by the SSA REC for each trial undertaken by the unit.

The name of the main REC and the REC reference number for the main
application should appear automatically at the top of the form.
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
The fields for the name of the SSA REC and REC reference number may be left
blank.
Question 1

Name of trial site
The trial site may be:



a private company or corporation (for example, a pharmaceutical or
biotechnology company or a Site Management Organisation)
a private hospital
a private clinical practice

You should also name any other locations at which trial procedures will be
conducted (excluding the analysis of data produced by the trial and production of
reports).

The SSA REC may wish to consider issues such as:



availability of necessary facilities and support services at these locations
(taking into account information given at Questions 22 and 24)
the capacity of the PI to supervise the research effectively across all locations
whether research participants will have easy and safe access to the site.
Question 2
Site Management Organisation

The Site Management Organisation may be the sponsor company itself or a
Contract Research Organisation which conducts the research on behalf of the
sponsor. In some cases it could be the company responsible for a private
hospital.

If no Site Management Organisation is involved (for example, where the research
is undertaken by a private clinical practice), state “None”.
Question 3

The individual with responsibility for monitoring the research on behalf of the
sponsor should be cited in all cases.
Question 4

Management and monitoring
Accreditation
Information about accreditation of Phase 1 trial sites by the Medicines and
Healthcare products Regulatory Agency (MHRA) is available at
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http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/Goo
dClinicalPractice/Background/index.htm#11

Please consult the GCP Inspection Team at the MHRA for further guidance on
the accreditation scheme and application process. Contact details are available
at the link above.

Where current accreditation is held, please enclose a copy of the accreditation
certificate with the application to the SSA REC.

Accreditation is not a legal requirement and is not a precondition for ethical
approval for the site. However, where accreditation is held this will provide a
robust assurance to the SSA REC of the general suitability of the site to conduct
Phase 1 trials and related research studies. Where the site is not accredited, the
SSA REC may require further documentation in support of the application, and
may wish to arrange its own visit to the site.

A number of questions in the SSI Form are disabled for sites with a current
accreditation from the MHRA, as they relate to issues routinely addressed by the
GCP inspectors within the accreditation process and do not need to be rereviewed by the REC for each trial undertaken by the unit.

Any significant changes at accredited sites, potentially affecting the accreditation
status (e.g. changes in key personnel, facilities or emergency procedures),
should be notified to the MHRA and SSA REC as soon as possible.
Question 5
Principal Investigator

The PI should submit a summary CV with information relevant to the current
application. It is recommended that applicants use the CV template available in
IRAS or, if not, the CV should include the areas of information in this template.
For example, it should give evidence of previous research in the same field of
study, and other relevant experience and training. The length should be a
maximum of 2 pages of A4. The CV should be signed and dated prior to
submission.

The SSA will include assessment of whether the local PI has the necessary
training and experience to undertake the research described in the proposal.
Question 6

Members of the local research team
List other members of the research team who will have a significant research role
(e.g. other clinical investigators, trial nurses, staff who will interview participants).
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Question 7

Conflicts of interest
Any potential conflicts of interest should be raised here. The SSA REC will
consider whether the issues raised pose any ethical concerns for the project.
Question 8
Local study dates

Give the proposed start date and the proposed end date for the research at this
site. These may differ from the overall study dates. You may not know these
dates exactly, but a rough estimate should be supplied.

For CTIMPs, please give planned end dates both for the final clinical intervention
(e.g. last administration of IMP) and the conclusion of all trial procedures (i.e. last
data capture).

For all other studies, the end date is the date on which all procedures specified in
the protocol are concluded.
Questions 9-2 and 9-2
Local variations in study procedures

The tables have been populated with information from Part A, completed by the
CI. Please insert details of the local members of the research team who will
conduct procedures.

If any variation is proposed in the interventions or procedures to be undertaken at
this site, select Yes. This will allow you to make any alterations to the information
in the table. The review will check that any variation is permitted within the terms
of the protocol and the full application submitted to the main REC. If not, the PI
should advise the CI to notify the main REC and seek ethical review of a protocol
amendment applicable to the site and, if appropriate, the local version of the
participant information sheet. SSA RECs do not have authority to approve such
amendments.
Question 11
Number of participants

If there is more than one group, state how many participants will be recruited in
each group.

“Participants” may include patients who are not approached but whose records or
samples are to be studied.
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Question 12

Recruitment of participants
Explain how potential participants will be identified and approached. Who will
review registers, lists or medical records to identify participants? Who will write to
potential participants inviting them to take part? Will potential participants be
referred from one organisation to another?
Question 13
Obtaining informed consent

The review will check that the person(s) taking informed consent locally are
appropriate for the task. They should be fully informed about the nature of the
study. They should be aware of the process of taking consent, including any
specific issues relating to consent with the potential participant population, and
familiar with “best practice”. Any specific training received should be described.

This person should have sufficient time and expertise to answer questions that
might be raised by the research participants.
Question 14-1

Adults with incapacity - CTIMPs
Explain what local arrangements will be made to seek consent from a legal
representative for the inclusion of adults unable to consent for themselves.
Question 14-2
Adults with incapacity – research in England and Wales

Explain what local arrangements will be made to seek advice from a consultee
before including adults unable to consent for themselves in the research.

This question applies only to conduct of the research at sites in England and
Wales.
Question 14-3
Adults with incapacity – research in Scotland

Explain what local arrangements will be made to seek consent from a guardian or
welfare attorney, or the adult’s nearest relative, before including adults unable to
consent for themselves in the research.

This question applies only to conduct of the research at sites in Scotland.
Question 14-4

Adults with incapacity – research in Northern Ireland
Explain what local arrangements will be made to seek assent from a close
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relative or other person before including adults unable to consent for themselves
in the research.

This question applies only to conduct of the research at sites in Northern Ireland.
Question 15
Emergency treatment

Explain what local arrangements will be made to recruit participants requiring
urgent treatment as part of the research. Say who will be responsible for making
decisions on their inclusion in the research.

Following the initial emergency, steps should be taken as soon as reasonably
practicable to seek:

informed consent from the participant (if capacity to consent has been
recovered)
or, if the participant has not recovered capacity,




informed consent from a legal representative (CTIMPs; non-CTIMPs at sites
in Scotland)
advice from a consultee under the Mental Capacity Act (non-CTIMPs at
sites in England and Wales)
assent from a close relative or friend (non-CTIMPs at sites in Northern
Ireland).
General provision to seek consent/advice/assent should be set out in the
protocol. Say what local arrangements will be made at this site.
Question 16

Participants should be informed how they may make a complaint, if necessary,
about the way they have been approached or treated in the course of the
research. The REC will wish to know what contact point for complaints will be
given on the participant information sheet to be used at the site.
Question 17

Complaints process
Independent contact point
It is good research practice to inform potential participants where they may obtain
either independent information or advice about their rights as research subjects
or about being involved in this particular research study. This may already be
included in the generic information sheet. However, if there is an appropriate
local source this should be cited here and added to the information sheet locally.
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If there is no appropriate individual or agency, please answer “No”.

The role of an independent adviser is to enable the participant to weigh up the
decision whether or not to participate, taking into account the information
provided about the study. Possible sources of advice include the following:



Another clinician or manager not involved in the conduct of the research
An information/support centre based at the site
An organisation specialising in support for patients in the relevant field.

Members of the research team should not be named as sources of independent
advice.

RECs should not be cited here. It is not the role of the REC to give direct advice
or support to participants in this way.
Question 18
Local version of the participant information sheet

The generic content of the participant information sheet is the responsibility of the
REC undertaking the main ethical review. Any variation to the generic content
must be approved by the main REC. Where the protocol allows variation
between sites (for example, a choice of standard treatment in the control arm or
imaging modality), the main REC may approve options in the participant
information sheet to be selected by the local PI in consultation with the CI.

If you consider that changes should be made to the generic content of the
information sheet to reflect site-specific issues in the conduct of the study, please
give details. A substantial amendment may need to be discussed with the Chief
Investigator and submitted to the main REC.

The SSA REC may not request changes to the generic content. However, it will
check that relevant site-specific information has been included in the local version
to make it suitable for local participants.

It is a requirement of Good Clinical Practice that participants should be able to
find out more information about the proposed research should they wish to do so.
Details must be included in the local version submitted for review.

Participants should be informed how they may make a complaint, if necessary,
about the way they have been approached or treated in the course of the
research. The contact point for complaints must be included on the local version.

It is important that the participant information sheet and any other
correspondence should be on “official” headed paper (e.g. of the Site
Management Organisation or private practice). Private (personal) headed paper
is not sufficient.
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Question 19
Language issues

Whether or not potential participants who may have difficulty understanding
English are (or are not) to be recruited is a general ethical issue for the main
REC.

If such participants are to be recruited, the minimum arrangements to be made
locally for provision of interpreters and information in other languages are an
issue for the main REC.

The local Principal Investigator should describe here how he/she will implement
those approved generic arrangements locally.

The Chief Investigator should have informed the PI of the availability of written
information for potential participants in other languages. It is the PI’s role to
ensure that these are available as appropriate to his/her site.

Where use of interpreters is desirable, the PI should describe the proposed local
arrangements for their availability.

For research sites in Wales, please consult the guidance on question A33-1 in
Part A of IRAS for meeting the requirements of the Welsh Language Act 1993.
Question 21

Information for professional carers
The review will check that those responsible for the professional care of a
participant are told of their involvement in the research. Sufficient details should
also be recorded in the patient’s medical records, to ensure that the future
treatment of the patient is compatible with their involvement in the study.
Question 22
Facilities and staffing

The SSA REC will check that the local facilities and staff are adequate for the
research to be undertaken safely, taking into account the specific procedures to
be undertaken and the potential risks.

Describe the standard systems in place to protect the safety of participants.

Describe any potential risks that could arise, and what arrangements have been
made to deal with these potential risks, to minimise harm to participants and to
respond to emergencies.
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
Where the research has the potential to cause significant distress or discomfort to
participants, describe any extra support that will be provided.

For phase 1 clinical trials and clinical investigations of medical devices, describe
the arrangements for medical care of participants.
Question 23

Describe what procedures are in place to check the previous and current
involvement of potential participants in other research, for example use of The
Over-Volunteering Protection System (TOPS). Further information about TOPS
is available at www.tops.org.uk .
Question 24

Over-volunteering
Management and monitoring arrangements
The SSA REC will wish to be assured that adequate arrangements are in place to
ensure the quality of the conduct of the research and monitor the safety of
participants.
Question 25
ARSAC certificate

This question is only applicable to research involving administration of radioactive
materials additional to normal care.

A research certificate from the Administration of Radioactive Substances
Advisory Committee (ARSAC) at the Department of Health will be required by the
nuclear medicine professional at each research site where the study involves
exposures that are additional to normal care. Most of the information required for
the ARSAC application can be generated from IRAS.

The ARSAC research application form can be launched either from the button at
Question 25 or by selecting the ARSAC tab. The form will be automatically
populated with relevant information from the SSI Form and Parts A-B of IRAS
once completed. The form should be transferred to the relevant nuclear medicine
professional at the research site, who will complete the remainder of the form and
submit it to the ARSAC Support Unit.

Where the only administration of radioactive materials is in accordance with
normal care at the site, this will be covered by the certificate holder’s normal
ARSAC certification.

Further guidance about ARSAC applications is available at
http://www.arsac.org.uk/
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
Guidance on arrangements for use of ionising radiation in research is available at
http://www.nres.npsa.nhs.uk/applicants/guidance/
Question 26
Insurance and indemnity

Describe the insurance or indemnity arrangements which will be in place to meet
any potential liabilities arising for the Principal Investigator, the Site Management
Organisation and other members of the research team arising from this research.

Where cover is arranged by the Site Management Organisation, please provide a
summary statement explaining what the policy provides and for whom, and how
the extent of the cover has been determined. Please confirm that the policy will
cover this particular research. Highlight any exclusions in the policy which may
limit the cover available. A copy of the insurance policy or certificate should be
provided.

It is not acceptable for the Site Management Organisation to provide an
undertaking to “self-insure” against the potential liability from its own funds. The
insurance or indemnity must be provided by another legal entity. It is acceptable
for the insurer to be another company within the same corporate group provided
it is a separate legal entity.

Where cover for the Principal Investigator is arranged through professional
indemnity insurance, a copy of the policy should be enclosed. Please confirm
that the insurance covers the conduct of this research as well as the PI’s normal
clinical practice.

This question does not apply to commercially sponsored Phase 1 trials. Under
the ABPI Guidelines for Phase 1 Clinical Trials (2007 edition), commercial
sponsors make a contractual undertaking to compensate a volunteer who has
suffered harm as a result of taking part in the trial whether or not the sponsor is
liable. The sponsor company will make its own arrangements to ensure that the
CRO and Principal Investigator have sufficient insurance or indemnity cover so
that it can recover any losses from them where the harm resulted from their
negligence. The main REC will seek assurance of the sponsor’s compliance with
the ABPI guidelines and evidence of insurance cover as part of the main review
of the trial.
Question 27 – supply and handling of IMP

If an IMP will be administered to trial subjects at this site, please provide details
of the arrangements for supply and handling of the IMP locally.

Guidance for sponsors is available in Section 5.14 of the ICH E6 Guideline on
Good Clinical Practice. This is available at either of the following:
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http://ichgcp.net/5-sponsor
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/20
09/09/WC500002874.pdf
Qualified Person (QP) release and certification

The terms QP release and QP certification, are often (incorrectly) used
interchangeably. However the responsibilities for release and certification are
defined in clinical trials legislation. EU Good Manufacturing Practice Annex 13,
Paragraph 44 requires that IMPs remain under the control of the sponsor until
after completion of a two-step procedure: certification by the QP; and release
following fulfillment of the requirements of Article 9 (commencement of a clinical
trial) of 2001/20/EC.

The QP has a legal responsibility as laid out in Article 13 of 2001/20/EC to ensure
that the IMP has been manufactured in accordance with EU GMP and meets the
conditions of the clinical trial authorisation and the product specification file
(PSF). In certifying a batch against the PSF, investigational medicinal product
dossier or the clinical trial authorisation (CTA) the QP is providing certification,
which has been known previously as the technical green light.

Release of IMPs for use in a clinical trial should not occur until after the QP has
certified the batch(s). Under Article 9 of 2001/20/EC, the sponsor may not start a
clinical trial until the clinical trial authorisation has been granted for the trial and
all conditions of the authorisation have been met; and an Ethics Committee
positive opinion has been granted and each trial site has been approved. The
process for ensuring that the appropriate approvals are in place has been known
previously as the regulatory green light.

For further guidance, refer to:
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/Good
ManufacturingPractice/Guidanceandlegislation/index.htm
IMP records

IMP records must be maintained to demonstrate adherence to the trial protocol
and credibility and integrity of the data. Such records may include but are not
limited to the following:
o
o
o
Original prescription
Randomisation code and code break
Drug accountability or dispensing records (including any marketed authorised
products used as IMPs, comparator or adjuvant therapy) and destruction
records
IRAS QSG – SSI Form (non-NHS sites)
Version 3.2 dated June 2011
15
o
o
o
o
o
o
Production worksheet or batch sheet
Written confirmation that QP certification has been performed
Storage temperature records including calibration records of temperature
monitors
Transit temperature records
Re-labelling records
Validation documents for electronic prescribing systems including validation
document for prescribing module or protocol set-up within the electronic
prescribing system.
Pharmacy support

Practice guidance on pharmacy services for clinical trials (June 2005) has been
published by the Institute of Clinical Research and the Royal Pharmaceutical
Society of Great Britain. The Royal Society no longer exists but the guidance
remains available from ICR at:
http://www.icr-global.org/community/special-interest-groups/pharmacy-specialinterest-group/

Although there is no legal requirement for pharmacy to be responsible for receipt
and storage of IMP for clinical trials, the ICR guidance states that:
“When a clinical trial is taking place in a hospital all IMPs should be stored
and issued by the hospital pharmacy and managed to the same standards as
licensed medicines. IMPs must not be stored in offices, clinics or ward areas
unless by prior agreement with pharmacy.”
Declaration

Please read the declaration carefully. By signing this, the Principal Investigator is
legally agreeing to its contents.
IRAS QSG – SSI Form (non-NHS sites)
Version 3.2 dated June 2011
16