CDISC SDTM ADaM TLF'S Training For Beginners

CDISC SDTM ADaM TLF'S Training For Beginners SAS programmer Work Description in clinical industry: The role of SAS programmers is to use their technical and programming skills to allow clinical trial statisticians to perform their statistical analysis work more efficiently. This may involve 1) Importing and exporting data from various sources, 2) Creating study data tables and creating analysis data sets as per regulatory guidelines 3) Creating clinical study report (CSR) materials consisting of tables, figures, and listings (TFL) 4) Exporting data and reports to Clients. As a SAS programmer we work on clinical trial data that is recorded during the live trail process. So, let’s see what is a “Clinical trial process”? Clinical Trail Process The Drug Development Process: The clinical trial industry is primarily concerned with bringing new drugs, devices, or therapies to the general population. In the US, most clinical trials are funded by pharmaceutical companies wanting to bring a new treatment to market or by the National Institutes of Health (NIH), which funds research to improve the health of all Americans. Because most of clinical trials are conducted with the idea to bring a new drug or device to market, we will briefly look at the U.S. Food and Drug Administration (FDA) approval process. Drug Approval Process: The FDA makes sure that all new drugs brought into market are both safe and effective. The FDA helps to do this with a drug approval process that can easily cost hundreds of millions of dollars and can take a decade or even more to move a drug from discovery to a pharmacy store near you. There are several progressive levels of studies that are conducted as part of the drug approval process. 1. Pre-clinical studies are the experiments that are conducted in the laboratory and with animals before a new drug is given to humans. If these studies are positive, the sponsor usually gets an Investigational New Drug (IND) application. The IND application allows the sponsor to conduct clinical trials of the new compound on human subjects. 2. Phase 1 trials are the “first in man” studies of a new drug in humans. These studies are usually carried out on small samples of subjects (around 20 – 30 patients). The idea here is to determine the safety of the drug in a small and usually healthy study population. 3. Phase 2 trials go beyond phase 1 studies in that they begin to explore the efficacy of a drug. Phase 2 studies have larger study population than phase 1 (around 100–200 patients). Safety is monitored at this stage as well, and phase 2 trials are generally conducted in the study population. 4. Phase 3 trials are large-scale clinical trials on population numbering in the hundreds to thousands of patients. These are the critical trials that the sponsor runs to show that new drug is both safe and efficacy in the study population. If the phase 3 trials are successful, they will submit the New Drug Application (NDA) form. 5. Phase 4 trials, or post-marketing trials, are usually conducted to monitor the long-term safety of a new drug after the drug is already available to consumers. INDUSTRY WORKFLOW: Let’s see the workflow of a SAS programmer in clinical industry, The below are the documents will be provided to “SAS programmers” and “Bio- Statistician” from sponsor or from concerned team(s) 1. Protocol 2. CRF 3. Study data (Raw data, trial data) [Study data - The data that is entered/recorded based on CRF document from each participant and stored in the form tables] 4. Study data specifications / Study data dictionary 5. Any other supporting documents necessary for understanding the study data and tables Once the documents are shared to “SAS programmers” and “Biostatistician”, the sequence of workflow starts with, 1. CRF Annotation: CRF Annotation is defined as - mapping between columns on a CRF form to datasets(domains) & variables from SDTM IG (implementation guide). 2. Creating SDTM mapping specifications document: It can be created manually as follows: 1. Examine the annotated CRFs and identify which SDTM domains/datasets and variables to be created. 2. For each domain that to be created, the specification document is created as an excel file using the annotated CRF and SDTM IG (implementation guide) 3. Creating datasets/domains and sharing: Creating datasets/domains as per specifications document, Once the datasets/domains are created, will be shared with the concerned team in the form of XPT files 4. Creating Analysis datasets: Based on SAP document and following AdaM IG (implementation guide), the specifications document is created, there by using those specifications document the analysis datasets are created. Once the analysis datasets are created will be shared with the concerned team in the form of XPT files. 5. TLF/G creation: Based on TLF/G mock shell document, Tables, Listings and graphs will be created for submission to concerned team.