Clinical Trials
A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health.
There are different kinds of clinical trials, including those to study:
- prevention options
- new treatments or new ways to use existing treatments
- new screening and diagnostic techniques
- options for improving the quality of life for people who have serious medical conditions
Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.
ComplianceOnline Training on Drugs Regulatory Requirements
Fundamentals of Clinical Research - Key players and roles for a successful and compliant research team
ICH guidelines and Good Clinical Practice (GCP)- Types and Phases of Clinical Trials - Role and responsibilities of Clinical Research coordinator - Principal Investigator - IRB
ICH guidelines and Good Clinical Practice (GCP)- Types and Phases of Clinical Trials - Role and responsibilities of Clinical Research coordinator - Principal Investigator - IRB
Critical Compliance and Major Changes for the EU Clinical Trials Directive
Requirements of the Clinical Trial Directive - key guidelines and documents - improving clinical trial application authorization - inspection
Requirements of the Clinical Trial Directive - key guidelines and documents - improving clinical trial application authorization - inspection
Making All Data Count: FDA Acceptance of non-US Clinical Trials
FDA acceptance of non-US clinical trials - Requirements for using clinical data from non-IND/IDE clinical trials - IND and/or marketing approval application
FDA acceptance of non-US clinical trials - Requirements for using clinical data from non-IND/IDE clinical trials - IND and/or marketing approval application
Budgeting for Clinical Trials: Understanding Costs of a Study and Which Costs Sponsors are Responsible to Cover
Start-Up Costs - Fixed Costs - Variable - hidden - overhead - qualifying trial and routine care - cost plan - negotiating a budget
Start-Up Costs - Fixed Costs - Variable - hidden - overhead - qualifying trial and routine care - cost plan - negotiating a budget
