What is an OSMB?
Table of Contents
What is an OSMB?
Observational Study Monitoring Board (OSMB) monitors observational studies with large or vulnerable populations or risks associated with tests or standard of care.
What is U01?
Pill with imprint U01 is White, Round and has been identified as Acetaminophen and Hydrocodone Bitartrate 325 mg / 5 mg. It is supplied by Aurolife Pharma LLC. Acetaminophen/hydrocodone is used in the treatment of back pain; pain; cough and belongs to the drug class narcotic analgesic combinations.
What counts as clinical research?
Clinical research is medical research involving people. There are two types, observational studies and clinical trials. Observational studies observe people in normal settings. Researchers gather information, group volunteers according to broad characteristics, and compare changes over time.
What is an ancillary study?
An ancillary study is an independent research project that uses samples or data from a parent study to extend knowledge in scientific areas beyond the original scope of the parent study.
What is a u01 grant NIH?
U01. Cooperative Agreements. Research Project–Cooperative Agreements. To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. More Information.
What is a u01 clinical trial?
The NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required) is for principal investigators (PIs) implementing a high-risk clinical trial. Applications must include project milestones, and NIAID staff have substantial scientific involvement during the award.
What is the difference between clinical trials and clinical research?
Clinical Trials A clinical trial is a type of clinical research study. A clinical trial is an experiment designed to answer specific questions about possible new treatments or new ways of using existing (known) treatments. Clinical trials are done to determine whether new drugs or treatments are safe and effective.
What does Arm mean in clinical trials?
Arm refers to each group or subgroup of participants in a clinical trial that receives specfic interventions (or no intervention) according to the study protocol.
What are the different phases of clinical trials?
Trial phases at a glance
| Phase | Number of people taking part | Is it randomised? |
|---|---|---|
| 1 | Small – often about 20 to 50 people | No |
| 2 | Medium – tens of people, sometimes over 100 | Sometimes |
| 3 | Large – hundreds or thousands of people | Usually |
| 4 | Medium to large, variable | No |
What is a U54 grant from NIH?
Resources. U54. Cooperative Agreements. Specialized Center–Cooperative Agreements. To support any part of the full range of research and development from very basic to clinical; may involve ancillary supportive activities such as protracted patient care necessary to the primary research or R&D effort.
What is an NIH uo1 grant?
U01. Research Project Cooperative Agreement. Supports discrete, specified, circumscribed projects to be performed by investigator(s) in an area representing their specific interests and competencies. Used when substantial programmatic involvement is anticipated between the awarding Institute and Center.
What is the difference between cohort and arm?
Multiple arms allow the effects of different interventions to be compared. Participants in a control arm may receive no intervention, placebo, or an intervention with a known effect. In observational studies, a pre-defined population may be observed over time and is termed, a cohort.
What is a 4 arm study?
A Four Arm Study to Evaluate the Safety and Efficacy of 3 Different Doses of RVX-100 Versus Placebo in Subjects With Irritable Bowel Syndrome Accompanied by Diarrhea (IBS-D) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
