Medical devices and drugs clinical research have their differences in approach and methodology. It is necessary to have a clear understanding of these differences if one embarks upon a study involving either or both of these.
Some of the major differences between device and drug clinical research include:
Requirement for a study:
One of the important differences between device and…Continue
Posted on November 23, 2017 at 6:17am
Misuse of social media is a critical area of HIPAA privacy. A random act of carelessness by a healthcare worker can result in a Protected Health Information (PHI) breach, inviting actions from the HHS. As is known, protection of patient health information is what HIPAA is essentially all about. Many…Continue
Posted on November 14, 2017 at 6:29am
The Federal-Wide Assurance (FWA) is an assurance given by an institution that is carrying out NIH-funded studies. Through this written assurance, which is required to be filed with the Office for Human Research Protections (OHRP); the institution commits itself to compliance with the terms of requirements set out in the HHS Protection of Human Subjects regulations at 45 CFR part 46. It is the only type of assurance that the OHRP accepts and approves.
The FWA must clearly outline the…Continue
Posted on November 13, 2017 at 5:45am
While it is true that all researchers want their studies to be reviewed and approved quickly; it has to be borne in mind that risks in the study can slow the process. Evaluation of risks is a fundamental requirement as stated in DHHS and…Continue
Posted on October 31, 2017 at 6:36am