2020 - Clinical Data Management (CDM)
Date2020-09-24 - 2020-09-25
Deadline2020-09-14
VenueBoston, MA, USA - United States
KeywordsClinical data management; FDA E6 GCP Guidelines; NIH Policy (SOP 15; 17; 19)
Topics/Call fo Papers
Regulatory guidelines for Clinical Data Management
Best practices for data collection
Responsibilities of personnel
Case report form criteria
Maintaining confidentiality of data
Data storage and transferability
Data preparation and quality assurance for accuracy
Data monitoring plan criteria
Data systems validation
Adverse event reporting and coding criteria
What to expect on a monitoring visit
Troubleshooting and resolution of deviations from plan
Best practices for data collection
Responsibilities of personnel
Case report form criteria
Maintaining confidentiality of data
Data storage and transferability
Data preparation and quality assurance for accuracy
Data monitoring plan criteria
Data systems validation
Adverse event reporting and coding criteria
What to expect on a monitoring visit
Troubleshooting and resolution of deviations from plan
Other CFPs
- Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
- Analytical Instrument Qualification and System Validation
- Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines
- I-9 Compliance & Audits in 2020
- Food Safety: Leadership Commitment
Last modified: 2020-05-19 22:35:30