Drug Development, Approval Process and Electronic Submissions (CDISC)

Development & Approval Process (Drugs) 
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm

Guidance Documents for Drug Applications 
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm090361.htm

Laws, Regulations, Policies and Procedures for Drug Applications 
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm090410.htm

How Drugs are Developed and Approved 
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm

Conducting Clinical Trials
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ConductingClinicalTrials/default.htm

Forms & Submission Requirements
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/default.htm

Electronic Regulatory Review
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm085358.htm

Electronic Regulatory Submissions
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm085324.htm

Electronic Regulatory Submissions and Review Helpful Links
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm085361.htm

Supporting CDISC Standards in Base SAS® Using the SAS® Clinical Standards Toolkit
http://www.nesug.org/Proceedings/nesug09/ph/ph14.pdf

CDISC Standards for submissions -

Although the Pharmaceutical companies do NOT have a common format for reporting/FDA Submissions, The CDISC and FDA are constantly pushing the companies to conform to CDISC standards. But the standards documents gives us a good oppurtunity to know more about the elements of Clinical trials. The ADAM, SDTM and CRT’s are the most important documents on the standards links to start with. Download The SDTM/SDSV3.x Zip Document – The SDTM Implementation Guide is the most important document from a developer perspective. This would list all the 23 domains and the datasets/elements that have to b submitted to FDA during ESubmissions.

You might want to read these topics at the least –

• 2.2 – Datasets and Domains
• 2.5 – Standard Domain codes….These are pretty much the sas datasets or the type of data that you would work in a clinical trial. The explanation or the columns in these domains are the ones that you would use in your programming. Chapters 5-9 give more details of all the Domains listed here in 2.5.
• 3.2.1 – This is a key summary of all the Domains described in 2.5 and Chapters 5 – 9. If u can byheart them it would be perfect. With this information you would which SAS dataset has what type of information and structure of the data (one record per subject or per medication/visit) and the primary key variables on the datasets.
• 3.2.3 – how to conform with CDISC.

CDISC: Why SAS® Programmers Need to Know http://www.blogger.com/www.lexjansen.com/pharmasug/2003/fdacompliance/fda055.pdf

Why CDISC? – Look at pg-5
http://www.nthanalytics.com/doc/Nth%20Analytics%20SDTM%20Case%20Study.pdf

Industry Standards for the Electronic Submission of Data to the FDA 
http://thenjchapterasa.org/njasa/Presentations/cdisca1.pot