Principles and Practice of Pharmaceutical Medicine

requiring suspected serious unexpected adverse
reactions (SUSARs) be reported electronically to
Eudra Vigilance, the European data processing net-
work. The Food and Drug Administration (FDA),
the US regulatory agency, has established the
Adverse Event Reporting System (AERS), a data-
base that accepts electronic individual case safety
reports.In addition, FDA is moving toward requiring
electronic submission of NDAs, amended new drug
applications (ANDAs) and biologics license appli-
cations (BLAs) using industry-accepted standar-
dized formats for data submission.
These trends have implications for the investi-
gative site. First, GCP guidelines require investi-
gators to report SAEs immediately to the sponsor
unless otherwise indicated in the protocol or inves-
tigator’s brochure (Figure 11.5). AEs are to be
reported to sponsors in accordance with the proto-
col. Complying with these reporting requirements
can be greatly facilitated if they are done electro-
nically. Second, to enable sponsors to conform to
the growing number of electronic submission
requirements, the clinical trial data that are col-
lected from dozens of sites across the globe are
more easily compiled and analyzed if the sites use
standardized electronic formats.

Accommodation for record storage

Clinical trials generate vast amounts of paperwork,
all of which must be stored during and after the

trials. With trials sometimes lasting for several

years and generally requiring more patients per

trial (Lamberti, 2005), storage requirements are

important regulatory and cost considerations for

the investigative site.

According to ICH GCP guideline 4.9.5, records

are to be retained until at least two years after the

last approval of a marketing application. Records

may be retained for even longer periods if required

by applicable regulatory requirements or if

required by the sponsor.

Trial-related documents can be stored offsite

once a trial is completed, but generally, while a

study is ongoing, it is more convenient to keep

them onsite. In particular, a visiting study monitor

will expect to have direct access to trial documents,

so having them readily available is important.

It is a good idea for the investigative site to plan

for excess document storage capacity in a location

that is dry and can be locked. Storing documents

in the basement of a building without special

protection from water damage or rodent destruc-

tion is not a good idea and is actually a violation of

GCP. ICH GCP guideline 4.9.4 states that the

investigator is responsible for storing documents

in a manner that will prevent their accidental or

premature destruction.

11.3 Clinical site challenges

Once basic infrastructure is in place, the challenge

of conducting successful clinical research begins.

Basic infrastructure provides the necessary frame-

work, but the essence of clinical research is defined

by specific tasks such as

patient recruitment and retention

budgeting

FDA audits.

Patient recruitment and retention

The recruiting of study volunteers and retaining

them throughout the study remains one of the

4.11.1All serious adverse events (SAEs) should

be reported immediately to the sponsor

except for those SAEs that the protocol

or other document (i.e. investigator’s

brochure) identifies as not needing

immediate reporting. The immediate

reports should be followed promptly by

detailed, written reports.

4.11.2Adverse events and/or laboratory

abnormalities identified in the protocol as

critical to safety evaluations should be

reported to the sponsor according to the

reporting requirements and within the

time periods specified by the sponsor in

the protocol.

Figure 11.5 ICH GCP Guidelines for SAE and AE report-
ing [Source:Safety Reporting Guideline for Good Clinical
Practice]

11.3 CLINICAL SITE CHALLENGES 133