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A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
A protocol is the study plan on which the clinical trial is based. Each trial is carefully designed to safeguard the health of participants as well as answer specific research questions. The protocol describes in detail what types of people may participate in the trial, the schedule of tests, procedures, medications, dosages, and length of the study.
SAP is the document that contains detailed information regarding the statistical methods and study objectives to help in the production of the Clinical Study Report (CSR) including figures, summary tables, and subject data listings for Protocol. Documentation of the program variables and algorithms that will be used to generate summary statistics and statistical analysis are also contained in this.
Patients who take part in clinical trials may benefit from the treatments they receive. As part of a clinical trial, a patient will receive either the experimental treatment being tested, an accepted standard treatment for the condition, or a placebo. It is important to understand that there is no guarantee that any treatment received in a clinical trial will produce the desired results.
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will remain secret and will not be mentioned in these reports (See Confidentiality Regarding Trial Participants).
What is Placebo?
Placebo refers to a powder, pill, or liquid that has no active ingredients. Placebo helps researchers to isolate the study treatment effect. They are a significant part of clinical studies. They give researchers a comparison point for new therapies to prove if they are effective and safe. Additionally, they provide the clinical data managers with the evidence they need to use to regulatory bodies to approve a new drug.
9) Emphasize The Importance Of Masking/blinding?
It removes any bias in the process of treatment that is investigated and that is why masking or blinding is required.
Define the Different Phases of Clinical Trials
There are four major clinical trial phases and include:
Phase I trials take one or more years and test one or more combinations of objectives. It also includes MAD, SAD, and food effect studies. Phase II trials last for one or two years and test the effective dose and the dosing regimen. Phase III trials range from 3 to 5 years and are called randomized, controlled, and multicenter trials and are significant for the approval of drugs. Phase IV trials are those that the regulatory authorities require the manufacturer to take for competitiveness.