We continue to reach out to our colleagues, customers, and friends in the most convenient places- from Facebook to Linked-In  to Twitter, and even in your very own inbox! Today we distributed the 21st issue of the IMARC e-Newsletter.

IMARC Research is announcing the addition of eight new team members to help accommodate our continued growth.  Seven of the employees will hold the position of clinical research associate (CRA) and one member will be joining the business staff.

In clinical research, the purpose of an Institution Review Board (IRB) is to review and approve research studies involving human subjects. Its purpose first and foremost is to protect patients by ensuring the rights, safety, and well-being of potential research subjects. 21 CFR part 56 contains general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations regulated by the FDA.

It’s official! According to the new guidance released on the FDA’s website all applicable clinical trials initiated on or after March 7, 2012, informed consent documents must be in compliance with the new requirement in 21 CFR § 50.25(c) and include this specific statement that refers to the trial’s description on http://www.clinicaltrials.gov: