Clinical Glossary:

Adverse Drug Reaction (ADR) ( See Definition )
Adverse Event (AE) ( See Definition )
Adverse Event Reports ( See Definition )
Assurance ( See Definition )
Biologic ( See Definition )
Biotechnology ( See Definition )
Blinding ( See Definition )
Case Report Form (CRF) ( See Definition )
Certified Research Coordinator (CCRC) ( See Definition )
Clinical Investigation ( See Definition )
Clinical Research ( See Definition )
Clinical Research Associate (CRA) ( See Definition )
Clinical Research Coordinator (CRC) ( See Definition )
Clinical Study Materials ( See Definition )
Clinical Trial ( See Definition )
Common Rule ( See Definition )
Consent Form ( See Definition )
Contract Research Organization (CRO) ( See Definition )
Control Group ( See Definition )
Data ( See Definition )
Data Management ( See Definition )
Deception ( See Definition )
Declaration of Helsinki ( See Definition )
Demographic Data ( See Definition )
Device ( See Definition )
Documentation ( See Definition )
Double-Blind ( See Definition )
Drug ( See Definition )
Drug or Device Accountability Records (DAR) ( See Definition )
Drug Product ( See Definition )
Effective Dose ( See Definition )
Efficacy ( See Definition )
Ethics Committee ( See Definition )
Exclusion Criteria ( See Definition )
Family Educational Rights and Privacy Act (FERPA) ( See Definition )
FDA Form 1572 ( See Definition )
Food and Drug Administration (FDA) ( See Definition )
Food Drug and Cosmetic Act (FD & C Act ) ( See Definition )
Formulation ( See Definition )
Generic Drug ( See Definition )
Good Clinical Practice (GCP) ( See Definition )
Human Subject ( See Definition )
In Vitro Testing ( See Definition )
In Vivo Testing ( See Definition )
Inclusion Criteria ( See Definition )
Informed Consent ( See Definition )
Institution ( See Definition )
Institutional Review Board (IRB) ( See Definition )
Investigational Device Exemption (IDE) ( See Definition )
Investigational New Drug Application (IND) ( See Definition )
Investigator ( See Definition )
Investigator?s Brochure ( See Definition )
Longitudinal Study ( See Definition )
MedWatch Program ( See Definition )
Monitor ( See Definition )
Monitoring ( See Definition )
Multiple Project Assurance ( See Definition )
National Institutes of Health (NIH) ( See Definition )
National Research Act ( See Definition )
New Drug Application (NDA) ( See Definition )
Nuremberg Code ( See Definition )
Off Label ( See Definition )
Office for Human Research Protection (OHRP) ( See Definition )
Open-Label Study ( See Definition )
Orphan Drug ( See Definition )
Over-the-Counter (OTC) ( See Definition )
Patient ( See Definition )
Pharmacoeconomics ( See Definition )
Phase I Study ( See Definition )
Phase II Study ( See Definition )
Phase III Study ( See Definition )
Phase IV Study ( See Definition )
Pivotal Study ( See Definition )
Placebo ( See Definition )
Pre-Clinical Testing ( See Definition )
Protection of Pupil Rights Amendment (PPRA) ( See Definition )
Protocol ( See Definition )
Protocol Amendment ( See Definition )
Quality Assurance ( See Definition )
Randomization ( See Definition )
Recruitment ( See Definition )
Recruitment Period ( See Definition )
Regulatory Affairs ( See Definition )
Research ( See Definition )
Research Team ( See Definition )
Risk-Benefit Ratio ( See Definition )
Safety Reports ( See Definition )
Serious Adverse Event (SAE) ( See Definition )
Single Project Assurance ( See Definition )
Source Data ( See Definition )
Source Documentation ( See Definition )
Sponsor ( See Definition )
Standard Operating Procedure (SOP) ( See Definition )
Standard Treatment ( See Definition )
Sub-investigator ( See Definition )
Subject/Study Subject ( See Definition )
Telephone Report ( See Definition )
Treatment IND ( See Definition )
Unexpected Adverse Drug Reaction ( See Definition )
Vulnerable Subjects ( See Definition )
Well-being ( See Definition )

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Types of Training Offered From the BioPharma Institute:

Live, In-person Training: The acquisition of knowledge, skills, and competencies as a result of having a live, in-person instructor is a wonderful way to train employees. However, the cost involved, the inconsistency of formats, and variety of quality among teachers all contribute to the extreme variability in its performance. Many companies spend lots of money providing unsuccessful training to its employees. At the BioPharma Institute we have a pool of live, in-person, instructors with proven experience delivering high-quality and effective training.

Computer-based Training: The activity of imparting and acquiring skills through training provided via computer, either offline or through the Internet, allows the trainee to learn at their own pace and review topics more than once through illustrations, reading text, and listening to online seminars. This can be a very effective, time- and cost-efficient, method of training. By incorporating progress checks, problem solving, case studies, and mnemonic learning aids, this form of training can be extremely successful. At the BioPharma Institute we have made computer-based training our expertise. We are proud to offer our SME-developed content and proven experience delivering high-quality and effective computer-based training to pharmaceutical and biotechnology companies around the world.

Blended Training: Blended Training incorporates both, Live, In-person Training with supplemented Computer-based training. This method allows for the added assurance that preparation for training has been performed by all learners. Many companies are now resorting to blended training to increase the performance of their training activities. At the BioPharma Institute, we have experience assisting companies with developing and implementing this activity into their delivery.

For more information on or the BioPharma Institute's other training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 800-4430, or email Support@BioPharmaInstitute.com.

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