hello everyone welcome to my youtube channel knowledge stone today i am going to discuss about top 25 interview question and answers for clinical data management friends i would like to request you all who are watching my video please like and subscribe my channel your support will motivate me to make more videos on job related and career related guidance so thank you so much to all of you who are supporting me from the beginning and without wasting any more time let's begin with our topic for today interview question and answers for clinical data management so what is clinical research clinical research is a branch of health care science that determines the safety and effectiveness which is also known as efficacy of medications devices diagnostic products and treatment regimens intended for human use these may be used for prevention treatment diagnosis or for relieving symptoms of a disease clinical research is a different from clinical practice in clinical practice established treatments are used while in clinical research evidence is collected to establish a treatment we will go to the next question what is clinical data management so clinical data management is the process of handling data from clinical trials the inherent goal of any clinical data management system is to produce and maintain quality data now the next question is what clinical data management professionals do in cdn process the main purpose of the cdm professional is to maintain the subject of patient data which is accurate clean and consistent for reporting to the regulatory body [Music] the next question is what are the phases of clinical trials there are four phases in clinical trial phase one which is known as human pharmacology trial phase 2 known as therapeutic exploratory trial phase 3 therapeutic confirmatory trial and phase 4 known as post marketing server surveillance trial what is ind or investigational new drug the agent which is tested in a clinical trial is called investigational new drug or ind what is ica gcp so this question is mainly asked and mostly asked freshers i must say who are looking for a job opportunity in clinical research field or in cdm or in pharmacovigilance so this common question is asked by most of the interviewers so do remember the definition of the ica gcp so ich stands for international council on harmonization and gcp stands for good clinical practice so guys whenever you are applying in any organization in clinical research or any health care industry do remember and always try to memorize the terminology in most of the part of technical round you you may be asked by the interview about about various terminology let's take an example of gcp they may ask you what is gcp so you by remembering the terminology you will be able to answer this question that gcp can be good clinical practice what is cdn cdm is clinical data management so let's talk about the definition of the ic gcp so good clinical practice is an international ethical and scientific quality standard for designing conducting recording and reporting trials that involve the participation of human subjects compliance with the standards provides public assurance that the rights safety and well-being of child subjects or patients are protected now we will move to the next question what is informed consent or known as icf so informed consent is the process of learning the key facts about a clinical child before deciding whether or not to participate it is also a continuing process throughout the study to provide information for participants so guys inform consent is mainly is one of the most crucial document and it is signed by the subject who are participating in the clinical trial the subjects will go through the informed consent and suppose the subject is illiterate illiterate or is not able to understand what is informed consent so a health care professional or the side personal will inform the subject of patient about all the terms and conditions in the informed consent so after signing the informed consent it is it can be the documented as an acceptance copy or authority to the research organization or the site that they can perform diagnostic tests on the subjects so it is the the signed copy of agreement is known by the subject or patient is known as the informed consent now we will go to the next question who sponsors clinical trial clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians medical institutions foundation voluntary groups and pharmaceutical companies in addition to federal agencies such as the national institute of health the department of defense and the department of veterans affairs so these are some of the example of the sponsor who funds or who initiate the clinical trial for a particular drug trials can take place in a variety of locations such as hospitals universities doctor's office or community clinics what is a protocol 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 describe what types of people may participate in the trial the schedule of tests procedures medications and dosage dosages and the length of the study guys i have made a separate video on protocol which is known as understanding of protocol you can go through that video so you will be able to understand the detail about the protocol what are the contents of the protocol and how it uh and what what are the different parts what are the parameters of protocol all the parts are all the contents are described in that video in detail so please go through that video [Music] what is crf crf is also known as case report phone is a specialized document in clinical research it should be study protocol driven robust in content and have material to collect the study specific data so crf is mainly and only used in clinical data management process so it can be an electronic copy or a paper copy where the patient data are maintained and stored [Music] can you give some example of case report forms used in clinical data management this is one of the most important question that is asked by the interviewers so here we will discuss about the forms which is used in clinical data management so some of the ecra forms are medical history ecg labs labs may include hematology chemistry thyroid and serology these are some of the examples of lab forms demographic physical examination adverse events vital signs in vital signs form it may include it bp heart rate so systolic diastolic heart blood pressures are documented in the vitals it etc are the example of case report form what is adverse event and what is adverse drug reaction an unexpected medical problem that happens during treatment with a drug or other therapy adverse event may be mild moderate or severe and may be caused by something other than the drug or therapy being given also called adverse effect so adverse event is divided into three part mild moderate or severe so do remember guys it is also asked in most of the interview that how you can how can you categorize or how adverse events are categorized an adverse drug reaction is a response to a medicinal product which is noxious and unintended response in this context means that a casual causal relationship between a medicinal product and an adverse event is at least a responsible possibility what is placebo so the 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 now we will move to the next question what are the stages of cdm so clinical data management is divided into three stages study startup study conduct and study close out so i have so friends i have made another video in detail about clinical data management process so i would like to request you all to please go through that video that will help you to understand the process about the clinical data management describe your daily routine as a clinical data manager so people who are experienced and are planning to for an interview or planning to join an organization this question is also asked for the entry level associates or the mid-level associates who are planning to switch in other organization that what kind of roles they perform during their work tenure in clinical data management process so i start my day suppose i am the clinical i am the person who is applying for a new or job in a new company or applying for a new role so i will explain like i start my day by processing clinical data such as recipient verification entry and filling of information i oversee or monitor the work that the data management project staff handle and develop data questions based on validation check what are the data questions it can be query that is raised during the data management process by the by looking into the validation checks or the listings or errors and omissions that i identified during data entry and resolve the problems now we will move to the next question what do you know about pkpt so pk is known as pharmacokinetics and pda is known as pharmacodynamic the main difference between pharmacokinetics and pharmacodynamics is the pharmacokinetics is defined as the movement of drugs through the body whereas pharmacodynamics is defined as the body's biological response to drugs that let me explain in a simpler manner pk defines that how the drug responds to the body and pd defines that how your body responds to the particular drug so in other words pk describes a drug absorption distribution metabolism and excretion also known as adme and pd describes how biological processes in the body respond to or are impacted by a drug now the our next question is what is discrepancy management so discrepancy management is the process that systematically addresses discrepancies generated within a study or within a clinical trial or clinical data management process for each discrepancy assigned to a user role a user must identify the cause assess the error and determine the appropriate action the user can choose to resolve the discrepancy or route it to another user how do you identify discrepancy in order to determine whether a discrepancy is unintentional or an undocumented intentional the information should be clarified with the prescriber the clarification can be done by sending query to the site personal in database or by sending an email what do you mean by subject status report in clinical child so subject status report created to identify if subjects has completed withdrawn if any death occurred or the subject is still in the study and it is marked as ongoing that means that subject is still enrolled and the process is ongoing but the trial is ongoing for that particular subject what is sae reconciliation this is one of the most important question or one of the most important topic you should remember it is a crucial part or we can say the essay reconciliation is the crucial parameter or process that takes place in the clinical data management process so essay reconciliation is reconciling the databases to be sure that the clinical trial adverse events are the same in the two databases what are those two databases it is clinical database and other one is safety database so i have already mentioned this in my previous video on clinical data management process so ae are the same in the two databases you is usually done periodically during the clinical trial rather than waiting till the end of the trial this corrects errors in near real time and avoids late expedited reports to health authorities what is source document a source document is a document in which data collected for a clinical trial is first recorded this data is usually later entered in the case report form or cra in which database clinical data management activities are performed so guys please remember that the clinic what are the databases where the clinical data the data's are maintained or subject data's are maintained so first one is medi-data rape inform oracle clinical and print clean trial what is freezing of data a database freeze involves revoking the right of the privileged user so that no more changes can be made to the database no questions can be added deleted or modified what is database log when the visit is when the last subject's visit is completed all the data cleaning activities are performed and it is ah and all the stakeholder comes to a point that the data is clean for that subject or for that study all the data's are clean so the user access is revoked for all users and databases log so no user can make any changes in database so guys there is a slight difference between database lock and freeze so first the freeze activity or soft lock is performed in soft lock data managers or the cdm professional can access work on the data or can edit the data but site personal are not authorized to work on the data or make any changes whereas in hard lock or in the database law the access is revoked for all the users or all the study personnel so they will not be able to login to that particular study to perform any activity so do remember this difference what is coding dictionaries are used in cdm so what are all coding dictionaries are used in the during medical code so the first one is medra it is used for coding of adverse events and medical history events using this dictionary is required whether whereas who drug de dictionary or who works in a similar way to medra but is used to code medications so that was all the questions 25 questions from my end related to the cds are the common questions which are asked by the interview viewer during technical rounds and even when you are performing any assessment or screening testing various organization these questions may also come as a part of the test so i guess i have covered all the topics the main topics that needs to be discussed in the what are the in questions that can come during for the pressures as well as for the entry level or mid-level associates who are planning to change their job in the data management or clinical data management domain so thank you so much guys thank you so much friends and if you like this if you think that you this video is useful for you please do subscribe my channel and hit the like button thank you so much