In the source SDTM AE dataset, there was only one record per patient per AE. So, what we needed to do in target ADaM ADAE dataset was to create duplicate records if one AE crossed-out treatment period. If duplicate records populated, then derive AE start date (ASTDT) as start date of corresponding treatment period, and AE end date (AENDT) as end date of corresponding treatment period. If a patient discontinued, then use dsstdt+30 as cut-off date.
Full Answer
How to derive end date from treatment 1 and treatment 2?
If AE starts in or before treatment 1 period and AE ends after treatment 1, then we need to derive AE end date as start date of treatment 2 minus 1 if treatment 2 start date is non-missing; or derive AE end date as end date of treatment 1 if treatment 2 start date is missing.
What does start date mean in clinical studies?
Study Start Date *§ Definition: The estimated date on which the clinical study will be open for recruitment of participants, or the actual date on which the first participant was enrolled.
What does final date mean in a clinical study?
Definition: The date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical study concluded according to the pre-specified protocol or was terminated.
Are all studied FDA-regulated device products previously approved by FDA?
Yes: At least one studied FDA-regulated device product has not been previously approved or cleared by FDA No: All studied FDA-regulated device products have been previously approved or cleared by FDA
What is a single-period parallel-design study?
single-period parallel-design study is one of the simplest study designs, and is still widely used. In this scenario, subjects are assigned to a single treatment arm, and receive one or more doses of a single investigational product during the course of the study. A schematic of the study design might look something like this:
Why use ADAM timing variables?
The main reason for the creation of the primary timing variables in ADaM is the need for analyzing study results using different time divisions than what has been collected or modeled in SDTM using EPOCH. For example, the SAP may define visit or time division windowing in order to guarantee that observations collected at a similar time interval from the start of the summary are summarized together, regardless of the CRF page on which they were recorded. Additionally, analysis time divisions may view the study epochs differently than how the data was collected. ADaM timing variables should reflect the analysis requirements, and not simply copy values from SDTM epochs or visits.
What is ADAMIG in clinical trials?
The CDISC Analysis Data Model Implementation Guide (ADaMIG) provides several timing variables for modeling clinical trial designs in analysis datasets. APHASE, APERIOD and ASPER can be used in conjunction with related treatment variables to meet a variety of analysis requirements, from single-period parallel studies to much more complicated situations involving multiple treatment periods and even different studies. The goal of this paper is to illustrate how some of these study designs may be handled in ADaM, and provide guidelines for selecting when to use the different timing variables that are available.
What is phase 1 in clinical trials?
Phase 1: Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients. Phase 1/Phase 2: Trials that are a combination of phases 1 and 2.
What is FDA oversight?
FDA-regulated Drug Product *§ ( Optional for Observational Studies ) Definition: Indication that a clinical study is studying a drug product (including a biological product) subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to section 351 of the Public Health Service Act.
What is the definition of clinical trial?
Definition: For a clinical trial of a drug product (including a biological product), the numerical phase of such clinical trial, consistent with terminology in 21 CFR 312.21 and in 21 CFR 312.85 for phase 4 studies. Select only one.
What is the record verification date?
Record Verification Date *#N#Definition: The date on which the responsible party last verified the clinical study information in the entire ClinicalTrials.gov record for the clinical study, even if no additional or updated information is being submitted.
What is a clinical study title?
Definition: A short title of the clinical study written in language intended for the lay public. The title should include, where possible, information on the participants, condition being evaluated, and intervention (s) studied. Limit: 300 characters.
