Search
 
 

Display results as :
 


Rechercher Advanced Search

Keywords

Affiliates
free forum


FDA Electronic data submission requirement

View previous topic View next topic Go down

FDA Electronic data submission requirement

Post  pallav on Thu May 24, 2012 3:41 pm

The following Document contains the specifications that are developed for submitting animal and human study datasets in electronic format. Datasets are views of the study data used by reviewers to conduct specific analyses of the study data. They may include both raw and derived data. Because of the unpredictability of the scientific review process, it is impossible to enumerate a priori all datasets needed for review. Prior to the submission, you should discuss with the review division the datasets that should be provided, the data elements that should be included in each dataset, and the organization of the data within the file. Additionally, not all FDA centers have adopted all aspects of these specifications; sponsors are advised to discuss with the reviewing division data needs prior to preparing data for submission.

Read the document here
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163561.pdf

pallav

Posts : 98
Join date : 2012-03-14
Location : Ahmedabad

Back to top Go down

View previous topic View next topic Back to top

- Similar topics

 
Permissions in this forum:
You cannot reply to topics in this forum