sponsor/CRO cannot arbitrarily make changes of
data.
Archiving
Systems must be in place to ensure that documents
will be securely retained for a long period of
time. The purpose of archiving is to safeguard all
documentation that provides evidence that a clinical
study has been conducted in accordance with the
principles of GCP. Archives at both the sponsor/
CRO and investigator sites must be reasonably
secure with regard to indexing, controlled access,
fire-resistance, flood-resistance and so on.
The investigator must be held responsible for
ensuring that all source documents, especially
records acquired in the normal practice of care
and treatment of a study subject, are safely
archived and available for inspection by authorized
company personnel or regulatory authorities.
Further, the investigator must archive all necessary
documents for a minimum of 15 years – the usual
industry standard. All appropriate clinical study
documents should be archived by the sponsor/
CRO, essentially for the lifetime of the product.
The specific documents to be retained are
described in the ICH GCP document.
12.6 Managing study
medications/devicesManagement of clinical study medications and
devices is a complicated activity, and many clinical
researchers report that they are not particularly
interested in this aspect of clinical studies: they
assume that it is all handled by other personnel in
the manufacturing facility. Meanwhile, personnel
in the manufacturing facility usually report that
they assume no further responsibility once the
supplies are released!
Preparation of study medications/
devices
The preparation of study medications or devices
and often rate limiting in initiating the study, parti-
cularly with double-blind designs. Requisition,
labeling and packaging are some of the important
considerations.
Requisition of study medication/device (includ-
ing placebo and comparator products, if relevant)
must be initiated at an early stage to allow sufficient
time to procure the study medications/devices
and to prepare the final labeling and packaging,
taking into account any special circumstances for
blind studies and for import requirements.
The principles of safe labeling and packaging
require compliance with the following principles:
the contents of a container can be identified;
a contact name, address and telephone number
is available for emergencies and enquiries; and
the study subject (or the person administering the
medication/device) is knowledgeable about storing
and administering the study medication/device,
and that the packing process can be audited against
a standard operating procedure.Shipment of study medications/devices
Clinical study medications/devices should not be
dispatched to study sites until all pre-study activ-
ities have been completed and regulatory require-
ments have been satisfied. The receipt of each
shipment of study medication/device should be
confirmed in writing by the investigator or phar-
macist (or other authorized personnel), who will be
instructed to return a completed ‘acknowledge-
ment of receipt form’ immediately. The recipient
at the study site will be instructed to contact the
sponsor/CRO immediately if there are any pro-
blems (e.g. missing or broken items, defects in
labeling, evidence of excursion from temperature
ranges) with the shipment. The recipient must be
particularly instructed to record the exact date of
receipt of the clinical supplies at the study site. This
information is necessary so that the monitor can
determine that the supplies were secure and cor-
rectly stored environmentally during the entire
period of shipment.
After the clinical study supplies have been sent
to the study site, the monitor must verify as soon as
possible that the supplies have arrived satisfacto-152 CH12 GOOD CLINICAL PRACTICES