Guidance on information requirements for “local pharmacy review” of research studies
(FAQs available)
A guidance document for NHS/ Sponsors/ CROs on the information required to support local pharmacy review, trial preparation and set up of research studies
EudraCT number:
Key documents/information
Protocol
Trial identifier:
Detail of information required
IRAS number:
Latest stage at which
information is needed
Pharmacy
SIV or
review
equivalent
Version submitted to regulatory authority


Sample label for each IMP or details of label text

Study Specific Information
Investigator’s brochure/SmPC
If not included in the protocol (or other documents supplied), the following documents/information should be provided:
Description of each IMP/ NIMP/ rescue
Name, strength, formulation, and packaging. State
medication
specific brand if required.

If the product not UK marketed, specify country of
manufacture.
Sample labels (or label text)
Source of supply of each IMP/ NIMP/ rescue e.g. Free of charge from sponsor / discounted supply
medication
from sponsor via reimbursement / local hospital supply

Storage conditions of each product supplied Specify temperature range for storage, minimum
by sponsor
monitoring requirements, deviation procedure.

Storage space requirements per study
Specify whether total storage space requirement is
likely to be under or over 0.5m 3. Where possible,
provide package dimensions of each product supplied
by sponsor.

Method of IMP reconstitution/ dilution/
preparation
If presentation not in a form ready for administration:
provide details of diluents, container, equipment to be
used, and information on safety handling requirement
(Material Safety Data Sheet - MSDS)

Stability & storage requirements of
reconstituted/ diluted/ prepared IMP
If presentation not in a form ready for administration:
provides details of storage requirements and stability of
the reconstituted/diluted/prepared IMP.

Source of supply of pharmacy consumables/ e.g. provided by sponsor / local hospital supply
equipment
(NB consumables/equipment provided by sponsor must
be CE marked)

e.g. No post trial arrangement/ compassionate use
program/ extension study available

Post trial arrangement for each IMP
Developed in conjunction with the Commercial Clinical Operations Group and endorsed by the National Pharmacy Clinical Trials Advisory Group.
Feedback on the use of the guidance document is welcomed to help inform its future development.
Email comments to [email protected].
Version: 2.0
Key documents/information
Detail of information required
Latest stage at which
information is needed
Pharmacy
review
Pharmacy involvement in
blinding/ unblinding process
Specify pharmacy’s responsibility. Provide details of
blinding/ unblinding process; e.g. staff involved,
equipment required.

Whether IXRS is used for dispensing by
pharmacy staff
Specify if pharmacy staff is required to access IXRS for
dispensing.

Process for product receipt and ordering
(for each product supplied by sponsor)
Include details of initial shipment, e.g. supplied at site
activation/ triggered by subject enrolment

Process for product disposal
(for each product supplied by sponsor)
e.g. returned to sponsor (pharmacy preference)/ local
site disposal (specify disposal certificate requirement)

Process for handling used/returned product Specify whether pharmacy is required to count and
record product(s) returned by subjects
(for each product supplied by sponsor)

Scheduling for laboratory measurements
(e.g. haematology/ chemistry)
Where dosage adjustment is dependent on laboratory
data, specify whether blood specimens must be taken
on the day of dosing or specimens can be taken in
advance in line with local procedure.
Dose banding criteria
(For oncology trials only)
Specify whether dose banding can be applied; if so,
specify which product(s) and criteria for dose banding.

Equations for calculating specific
parameters
(e.g. Body Surface Area, Creatinine clearance)
e.g. calculate in line with local practice/ calculate using
a specific equation (please specify)

IXRS manual (if relevant)
Provide IVRS or IWRS manual if relevant
Delegation log
Specify whether:
 Sponsor agreement to use local templates
 Sponsor to provide documents
Temperature log is usually not necessary, as access will
be provided to temperature records that are recorded
and stored centrally by pharmacy.





i.e. if unlicensed product, sponsor to provide QP
certificate or assurance of QP certification.

Prescription form
Accountability log
Disposal/destruction log
Assurance of QP certification
Study Specific Information
SIV or
equivalent

Developed in conjunction with the Commercial Clinical Operations Group and endorsed by the National Pharmacy Clinical Trials Advisory Group.
Feedback on the use of the guidance document is welcomed to help inform its future development.
Email comments to [email protected].
Version: 2.0