| |
|
|
| ICH |
> |
International Conference of Harmonization
|
| CDC |
> |
Clinical data coordinator |
| CDC |
> |
Centers for Disease Control |
| ADR |
> |
|
| CDER |
> |
Center of Drug Evaluation and Research |
| AE |
> |
Adverse event |
| CDISC |
> |
Clinical Data Interchange Standards Consortium
|
| CDM |
> |
Clinical Data Management |
| BLA |
> |
Biologics License Application
|
| CFR |
> |
Code of Federal Regulations |
| CRA |
> |
Clinical research associate |
| cGMP |
> |
Current Good Manufacturing Process |
| CONMEDS |
> |
Concomitant medications |
| CRC |
> |
clinical research coordinator |
| e-CRF |
> |
Electronic Case Report Form |
| CRF |
> |
Case report form |
| CRO |
> |
Contract Research Organization |
| CRS |
> |
Clinical research scientist |
| DCF |
> |
Data clarification form |
| EDC |
> |
Electronic Data Capture |
| EC |
> |
Ethics committee
|
| IEC |
> |
Independent ethics committee |
| IRB |
> |
Institutional review board |
| FDA |
> |
Food and Drug Administration |
| GCP |
> |
Good Clinical practice |
| EMR |
> |
Electronic medical record |
| GCDMP |
> |
Good Clinical Data Management Practice |
| GLP |
> |
Good Laboratory Practices |
| GMP |
> |
Good manufacturing practice (cGMP) |
| NDA |
> |
New Drug Application |
| PI |
> |
Principal Investigator |
| SDV |
> |
Source data verification |
| SBOA |
> |
Summary basis of approval |
| NCR |
> |
No carbon required (CRF) |
| IP |
> |
Investigational product |
