credentials of investigators and sub-investigators,
adverse event reporting and participation in site
inspections are some of the many responsibilities
assumed by the regulatory affairs department.
Generally, small and part-time sites cannot jus-
tify creating a position for a full-time regulatory
manager, but once the number of studies con-
ducted annually approaches eight or more, a full-
or part-time regulatory affairs position needs to be
created. Without this function firmly in place, it
becomes increasingly difficult to maintain site
quality. Signals that staffing in regulatory affairs
needs to be increased include the failure to submit
important regulatory documents in accordance
with established timelines, difficulty in keeping
regulatory binders up-to-date and failure to report
adverse event (AE) and serious adverse events
(SAE) to sponsors or ethics committees as
required.
Data management and increased use
of electronic solutionsAs clinical trial protocols increase in complexity,
there is an industry-wide shift toward adoption of
electronic solutions to improve critical functions,
most notably the collection, handling, analysis and
storing of clinical data and the reporting of adverse
and serious adverse events.
Traditionally, the collection of data at the inves-
tigative site has been and, to a large extent, con-
tinues to be accomplished using paper and pen, but
in recent years, there is growing emphasis on elec-
tronic methods. Estimates vary as to the percentage
of electronic solutions used to collect and submit
clinical data, but they are generally in the range of
15–20% of clinical trials (Borfitz, 2004). This
number is expected to increase over time as more
pharmaceutical sponsors commit to implementing
electronic data capture (EDC) in virtually all of
their clinical trials (Bleicher, 2005).
For the investigative site, shifting away from
paper in favor of electronic solutions means that
staff must be trained in both types of data collection
during this transition phase. The quality assurance
department should create SOPs for both methods
because the capturing and handling of clinical data
are completely different for ‘paper-based’ and
‘electronic studies’. In a paper-based study, clinical
source data are handwritten onto paper CRFs that
are mailed, faxed or overnighted to the sponsor or
CRO. In a study using EDC, data are entered
electronically into a secured Web-based CRF that
is sent via the Internet to the sponsor or CRO. Data
that are missing, placed in the wrong field or out of
range are immediately spotted, thereby reducing
the number of queries. And, to facilitate the more
rapid sending of electronic data to sponsors or
CROs, allowing near real time viewing of those
data, the site should implement high-speed Internet
access.
Regulatory pressures are also driving increased
use of electronic solutions (Beysteret al., 2005).
Regulatory agencies around the globe are requiring
that more trial-related information be submitted
electronically. For example, on May 1, 2004,
European Medicines Agency (EMEA), the regula-
tory body for the EU member states, started- Telephone screening
- Sign-in sheet
- Schedule book
- Confirming appointments
- Informed consent process
- Amended consents
- Screen failures
- Tracking forms
- Serious adverse events
- Master charts
- Source documents
- Progress notes
- Obtaining medical records and notifying
primacy care physician - Storage of records
- Patient stipend
Figure 11.4 Some study management SOPs [Source:
Miskin and Neuer, How to Grow Your Investigative Site,
2002 ]
132 CH11 SITE MANAGEMENT