ABPI Guidelines for Phase 1 Clinical Trials (PDF

• report to the sponsor, within the time frame
identified in the protocol, all serious adverse
events (SAEs), except those identified as exempt
in the protocol or investigator's brochure; and
• provide follow-up reports of SAEs, and any other
information requested, within the time frame
identified in the protocol.
The sponsor must:
• report to the MHRA:
- suspected unexpected serious adverse reactions
(SUSARs) that occur in the trial and are
associated with any IMP used in the trial; and
- SUSARs that are associated with any IMP used
in the trial and that the sponsor learns about
from other sources, for example, a SUSAR that
occurs in another trial;
• report to the REC:
- SUSARs that occur in the trial at a site in the UK
and are associated with any IMP used in the
trial; 24 and
- SUSARs that are associated with use of any of
the IMP in the UK (for example, a SUSAR in
another trial), if the IMP is not marketed in
the EU;
• report to the investigator(s):
- SUSARs as they occur, but without unblinding
the investigator.
Sponsors must report fatal or life-threatening SUSARs
to the MHRA and REC within 7 days, and provide
further information within another 8 days, and report
all other SUSARs within 15 days.
Sponsors may delegate their responsibilities to the
investigator, providing the investigator is not unblinded
in the process.
24. Pathology laboratory
General
All units should have access to a pathology laboratory
for assays of blood, urine and other body fluids. Some
units may have their own laboratory, whereas others
may use a subcontractor.
The laboratory should have external accreditation,
such as Good Laboratory Practice 83 (GLP), College of
American Pathologists 84 (CAP), Clinical Pathology
Accreditation 85 (CPA) or ISO 17025. It should be
inspected regularly and participate in continual
improvement schemes, such as NEQAS. 86
© Association of the British Pharmaceutical Industry 2007
Premises. facilities, equipment and
procedures
The pathology laboratory should:
• be purpose-built or adapted for the purpose;
• have automated equipment for routine
haematology, biochemistry and serology tests;
• have procedures for analyser calibration and
quality control;
• regularly maintain all the equipment, including
point-of-care equipment;
• have a procedure for transporting samples safely
and quickly from clinical areas to the laboratory;
• have written procedures for all assays, and
validate the assays;
• have a stock control procedure to make sure that
reagents and consumables are used within their
expiry dates;
• keep records, including source documents and
final reports;
• have a procedure for authorising and releasing
results;
• have a procedure for 'flagging' and notifying
medical staff of abnormal results;
• have a laboratory information management
system, and validate and backup the system;
• provide protective clothing and safety equipment
for staff;
• have a central alarm system for all fridges and
freezers; and
• have an internal audit programme.
Staff
The number and type of laboratory staff will depend
on the workload, the complexity of the work, and
the extent to which the equipment is automated
and computerised.
Laboratories usually have a head of department, with a
professional qualification such as FIBMS, who is
responsible for the scientific and technical work,
staff management and training, and administration.
There should be enough trained and competent staff to
ensure a good service for specimen turnaround times,
completion of acute work on the day of its receipt,
and arrangements for urgent specimens. All staff
must follow the laboratory's SOPs and the Institute
of Biomedical Science guidelines, 87 and receive
GCP training.
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