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• CONDITIONAL STATEMENTS, if then ELSE.
• PUT STATEMENT
• Debug option.

Programmers sometime hardcode when they need to produce report in urgent. But it is ALWAYS better to avoid hardcoding, as it overrides the database controls in clinical DATA management. Data often change in a TRIAL over time, and the hardcode that is written today may not be valid in the future.Unfortunately, a hardcode may be forgotten and left in the SAS program, and that can lead to an INCORRECT database change.

Programmers sometime hardcode when they need to produce report in urgent. But it is always better to avoid hardcoding, as it overrides the database controls in clinical data management. Data often change in a trial over time, and the hardcode that is written today may not be valid in the future.Unfortunately, a hardcode may be forgotten and left in the SAS program, and that can lead to an incorrect database change.

• Demog
• Adverse EVENTS
• Vitals
• ECG
• Labs
• Medical HISTORY
• PhysicalExam etc

ISS (Integrated summary of safety):Integrates safety information from all sources (animal, CLINICAL pharmacology, controlled and uncontrolled studies, epidemiologic DATA). "ISS is, in part, simply a summation of data from individual studies and, in part, a new analysis that goes beyond what can be done with individual studies."ISE (Integrated Summary of efficacy)ISS & ISE are critical components of the safety and effectiveness submission and expected to be submitted in the application in accordance with regulation. FDA’s guidance Format and Content of Clinical and STATISTICAL Sections of Application gives advice on how to construct these summaries. Note that, despite the name, these are integrated analyses of all relevant data, not summaries.

ISS (Integrated summary of safety):Integrates safety information from all sources (animal, clinical pharmacology, controlled and uncontrolled studies, epidemiologic data). "ISS is, in part, simply a summation of data from individual studies and, in part, a new analysis that goes beyond what can be done with individual studies."ISE (Integrated Summary of efficacy)ISS & ISE are critical components of the safety and effectiveness submission and expected to be submitted in the application in accordance with regulation. FDA’s guidance Format and Content of Clinical and Statistical Sections of Application gives advice on how to construct these summaries. Note that, despite the name, these are integrated analyses of all relevant data, not summaries.

What are the variables in adverse event datasets?The adverse event DATA set contains the SUBJID, body SYSTEM of the event, the preferred term for the event, event severity. The purpose of the AE DATASET is to GIVE a summary of the adverse event for all the patients in the treatment arms to aid in the inferential safety analysis of the DRUG.

What are the variables in adverse event datasets?The adverse event data set contains the SUBJID, body system of the event, the preferred term for the event, event severity. The purpose of the AE dataset is to give a summary of the adverse event for all the patients in the treatment arms to aid in the inferential safety analysis of the drug.

It is a PLANETARY MEETING of all the project managers to discuss about the present Status of the project in HAND and discuss new ideas and OPTIONS in improving the Way it is presently being PERFORMED.

It is a planetary meeting of all the project managers to discuss about the present Status of the project in hand and discuss new ideas and options in improving the Way it is presently being performed.

SAS documentation INCLUDES programmer header, COMMENTS, titles, footnotes ETC. Whatever we type in the program for making the program EASILY readable, easily understandable are in called as SAS documentation.

SAS documentation includes programmer header, comments, titles, footnotes etc. Whatever we type in the program for making the program easily readable, easily understandable are in called as SAS documentation.

This document contains detailed information regarding study OBJECTIVES and statistical methods to aid in the production of the CLINICAL Study Report (CSR) including summary tables, figures, and subject data LISTINGS for Protocol. This document also contains documentation of the program variables and algorithms that will be used to generate summary statistics and statistical analysis.

This document contains detailed information regarding study objectives and statistical methods to aid in the production of the Clinical Study Report (CSR) including summary tables, figures, and subject data listings for Protocol. This document also contains documentation of the program variables and algorithms that will be used to generate summary statistics and statistical analysis.

I have USED VERSION 3.1.1 of the CDISC SDTM.

I have used version 3.1.1 of the CDISC SDTM.

I have worked with DEMOGRAPHIC, adverse EVENT , laboratory, ANALYSIS and other DATA SETS.

I have worked with demographic, adverse event , laboratory, analysis and other data sets.

I have used MANY PROCEDURES like proc report, proc sort, proc format etc. I have used proc report to GENERATE the list report, in this PROCEDURE I have used subjid as order variable and trt_grp, SBD, dbd as display variables.

I have used many procedures like proc report, proc sort, proc format etc. I have used proc report to generate the list report, in this procedure I have used subjid as order variable and trt_grp, sbd, dbd as display variables.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Most human use of investigational new drugs takes place in controlled clinical trials conducted to assess the safety and efficacy of new drugs. Data from these trials are used to determine whether a drug is SAFE and effective, and serve as the basis for the drug marketing application. Sometimes, patients do not qualify for these controlled trials because of other health problems, age, or other factors, or are otherwise unable to enroll in such trials (e.g., a patient may not live sufficiently close to a clinical trial site).

For patients who cannot participate in a clinical trial of an investigational drug, but have a serious disease or condition that may benefit from treatment with the drug,FDA regulations enable manufacturers of such drugs to provide those patients access to the drug under certain situations, known as "expanded access." For example, the drug cannot expose patients to unreasonable risks given the severity of the disease to be treated and the patient does not have any other satisfactory therapeutic options (e.g., an approved drug that could be used to treat the patient's disease or condition). The manufacturer must be WILLING to make the drug available for expanded access use. The primary intent of expanded access is to provide treatment for a patient's disease or condition, rather than to collect data about the study drug.

Some investigational drugs are available for treatment use from pharmaceutical manufacturers through expanded access programs listed in ClinicalTrials.gov. If you or a loved one is INTERESTED in treatment with an investigational drug under an expanded access protocol listed in ClinicalTrials.gov, review the protocol ELIGIBILITY criteria and inquire at the Contact Information number. If there is not an expanded access protocol listed in ClinicalTrials.gov, you or your health care provider may contact a manufacturer of an investigational drug directly to ask about expanded access programs.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Most human use of investigational new drugs takes place in controlled clinical trials conducted to assess the safety and efficacy of new drugs. Data from these trials are used to determine whether a drug is safe and effective, and serve as the basis for the drug marketing application. Sometimes, patients do not qualify for these controlled trials because of other health problems, age, or other factors, or are otherwise unable to enroll in such trials (e.g., a patient may not live sufficiently close to a clinical trial site).

For patients who cannot participate in a clinical trial of an investigational drug, but have a serious disease or condition that may benefit from treatment with the drug,FDA regulations enable manufacturers of such drugs to provide those patients access to the drug under certain situations, known as "expanded access." For example, the drug cannot expose patients to unreasonable risks given the severity of the disease to be treated and the patient does not have any other satisfactory therapeutic options (e.g., an approved drug that could be used to treat the patient's disease or condition). The manufacturer must be willing to make the drug available for expanded access use. The primary intent of expanded access is to provide treatment for a patient's disease or condition, rather than to collect data about the study drug.

Some investigational drugs are available for treatment use from pharmaceutical manufacturers through expanded access programs listed in ClinicalTrials.gov. If you or a loved one is interested in treatment with an investigational drug under an expanded access protocol listed in ClinicalTrials.gov, review the protocol eligibility criteria and inquire at the Contact Information number. If there is not an expanded access protocol listed in ClinicalTrials.gov, you or your health care provider may contact a manufacturer of an investigational drug directly to ask about expanded access programs.

Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or LIFESTYLE changes.

Diagnostic trials are conducted to FIND better tests or procedures for DIAGNOSING a particular disease or condition.

Screening trials test the BEST way to detect certain diseases or health conditions.

Quality of Life trials (or Supportive CARE trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.

Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening trials test the best way to detect certain diseases or health conditions.

Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

CLINICAL trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical INSTITUTIONS, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as HOSPITALS, universities, DOCTORS' offices, or community clinics.

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.

Ideas for clinical trials usually come from researchers. After researchers test NEW therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most promising laboratory RESULTS are moved into clinical trials. During a trial, more and more INFORMATION is gained about an experimental TREATMENT, its RISKS and how well it may or may not work.

Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about an experimental treatment, its risks and how well it may or may not work.

YES. A participant can leave a CLINICAL trial, at any time. When withdrawing from the trial, the participant should LET the research team KNOW about it, and the reasons for leaving the study.

Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

Yes. Most clinical trials PROVIDE short-term TREATMENTS related to a designated illness or CONDITION, but do not provide extended or COMPLETE primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the PROTOCOL.

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

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.

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.

The clinical trial process depends on the KIND of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the PARTICIPANT at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

Some clinical trials involve more tests and DOCTOR visits than the participant WOULD normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most SUCCESSFUL when the protocol is carefully followed and there is frequent contact with the research staff.

The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.