Now we all did visit the FDA website and felt it was a bit out-of-fashion. FDA has listened to us and have come up with new look website, check it out at www.fda.gov.
ADaM is a CDISC standard to submit analysis data to FDA. Key is to understand that ADaM is a SDTM model for providing analysis data, programs and data definitions. The principles of ADaM is aimed at providing a clear and unambiguous communicationof the content, source and quality of the datasets submitted in support of the statistical analysis performed by the
sponsor. This in turn would support the machine-readable description for the JANUS data repository.
Analysis datasets are datasets created to support specific analyses.
Programs
Programs are scripts used with selected software to produce reported analyses based on these datasets.
Analysis-level Metadata
Define.xml is the document which specifies the standard for providing Case Report Tabulations Data Definitions in an XML format for submission to regulatory authorities (e.g., FDA).
The XML schema used to define the expected structure for these XML files is based on an extension to the CDISC Operational Data Model (ODM).
In the picture below the key aspects are highlighted with the red text, basically it is a listing of data items that a sponsor will transmit to FDA along with the regulatory application.
Each data set if furthered detailed with what data items are sent and their nature (ex: Derived or from a CRF page)
The following general guidelines are proposed by FDA in reference in Computerized systems in clinical trials, the complete document is available at http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm
C. Source documents should be retained to enable a reconstruction and evaluation of the trial.
F. Clinical investigators should retain either the original or a certified copy of all source documents sent to a sponsor or contract research organization, including query resolution correspondence.
The ground truth of how pharmaceutical industry has evolved over the past decade is the large surge in increased specialization and sophistication. In this series we will focus on specialist careers in pharmaceutical industry, lets start with pharmacovigilance.
No medicine which is effective is 100% safe, but the adverse/side effects of a drug have to be weighed against the benefits of the drug. For example a drug treating terminal disease like cancer can have some adverse effects like vomiting and hair loss, but still it would be approved given the gravity of disease it is used to treat. Drug safety function focuses on measurement, prediction, reporting and evaluating safety signals. There are several roles in this domain namely :
If you are good at either synthesising medical information/research finding or have great analytical capabilities to drill down into complex safety data this area of specialization is very suitable and lucrative for you.
Recently we were looking for some SAS experts to work for clients in US, UK and Singapore, the response as always was huge (200+ resumes), for some of those that looked outstanding we had a telephone interview with only one question : Why SAS ?, unfortunately only 2 candidates knew why SAS was relevant in clincial research.
If you know why SAS please feel free to let us know using the comments option below
