Clinical research documentation

We must be sure to document our efforts and our findings. Clinical research
documentation is a continually expanding industry because of growing biotechnology.
Salaries are paid based on ones qualification and also on their background and education.
If you have the experience, flexible job options (home based, part-time, consultant) are
available. Travel and in-house jobs are available too.

Clinical research documentation- job profile.

The job profile could be that of a data coordinator, clinical data reviewer, medical
communications consultant, drug safety specialist, or clinical research coordinator
depending on your qualification and experience.

Research conditions keep changing over time and documentation should reflect all the
research practices. So, the ongoing clinical research and the progress must be
documented. Clinical research documentation is also useful for other purposes such as
insurance, lawyers and other physicians. Laboratory, imaging and specialist consults
must also be included in the documents. The clinical impressions and the case progress
should be incorporated in a clinical research document.

The document should accurately reflect clinical thought processes and should document
the person’s status and how the patient has progressed since research was initiated. This
aspect of documentation should not be neglected and correct charting will help in
successful researching.

A Clinical Research Associate (CRA) is an individual who oversees the progress and
conduction of a clinical trial that is usually implemented by physicians at hospitals,
clinics, or research foundations. The CRA frequently has a background of nursing,
medical technology, physical therapy, bachelor's, masters, or a Ph.D. in a science and is
employed by a pharmaceutical company, research organizations, or an academic
institution. A CRA plays an important role in documenting drug development and thus
marketing the tested drugs. The demand for trained CRAs is growing but the availability
is quite limited.

Documents should have easy data entry procedures and simple review procedures.
Abbreviations can be used, but should be standardized. Interpretation by others should be
possible. Documents can be of great use when other specialists need information on the
research.

Responsibilities may include the following:

• Monitoring that the research follows proper clinical practices and the maintenance
of accurate protocol.
 • Perform a study on drug (drug under study) liability;
• Verify that the documentation of the informed consent process for each study
subject is accurate and periodic.
• See that all the adverse experiences are correctly reported and documented
• Check the completeness and accuracy of the case report.
• Monitor that the documentation is done every day or periodically.
• Try to increase the uses and the efficiency of clinical documentation.
• Ensure efficient chart organization.
• Check efficient chart renewal.

There are two problems involved with research-oriented recordkeeping. First of all, it
takes practice and time to learn to use it effectively. This could stop research
organizations from adopting such a system, especially when it involves modifying
existing documents and documentation practices. The second disadvantage is that it needs
an extra time for day-to-day chart entries. When documentation is not done, either the
research steps get forgotten or wrongly interpreted. Sometimes it could be concluded that
a particular incident did not occur at all.

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