| What is a CRA / CRC?
|
|
A Clinical Research Associate (CRA) can also be called a
Monitor, a Clinical Monitor, a Trial Monitor or a Medical Monitor. The title
will vary from organisation to organisation. The job description will be the
more or less same. A CRA is an individual employed by a pharmaceutical or
device manufacturer, by a contract research organization (CRO) usually acting
on a sponsor's behalf or by an academic institute conducting clinical trials.
Regulations require that sponsors of clinical studies select individuals who
are qualified by training and experience to monitor their studies 21 CFR 312.53
(d). ICH Guidelines 5.18.2 (b) also states that Monitors be appropriately
trained and their qualifications documented.
|
| Cliniminds Program Provides
this Required Training |
| The major responsibilities of a CRA are : |
|
-
Assure the protection of the rights, safety and well being of human study
subjects.
-
To analyze and evaluate clinical data, to ensure investigator and site
compliance with the study drug protocol, overall clinical objectives, FDA
regulations, ICH Guidelines, Good Clinical Practice (GCP).
-
Identify, help in the study site selection process, initiate, and eventually
close out clinical study sites.
-
To monitor the progress of clinical study sites participating in a clinical
study, and to assure the protocol is followed and data is reported accurately.
-
To make certain that the scientific integrity of the data collected is
protected and verified.
-
Assure that adverse events are correctly documented and reported.
-
Review all case report forms and compare them to source documents.
|
|
This distance learning training program teaches you all the
responsibilities of the CRA.
|
|
| What is a Study Coordinator or Clinical
Research Coordinator? |
|
This is the position who works for the Investigator /
institution who handles most of the administrative responsibilities of a
clinical trial, is the liaison between the clinical trial investigative site
and the sponsor of the clinical trial, and reviews all data and records before
a CRAs visit. The title can be research nurse, trial coordinator, study
coordinator, research coordinator, or clinical coordinator.
|
|
|
|
|