Introduction to Clinical Data Management Training:
Clinical Data Management Training at Idestrainings – Clinical Data Management is a very crucial process in clinical research because the data collected during clinical trial is analyzed for Safety and efficacy. This analysis forms a basis for decision making on product development in the pharmaceutical industry. Clinical Data Management is a process of managing clinical data which encloses Data design, Data collection, Data entry, Data validation, Data cleanup, Data analysis, Data reporting and Data presentation. Idestrainings is best in providing CDM Online Training by industry experts at flexible timings.
What is CDM?
- The prime objective of CDM process is to produce high quality data from final analysis. High Quality data refers to the data which comply with the protocol specifications and are accurate and suitable for statistical analysis. Approval of investigation product depends on the integrity of clinical data to produce authority by data developers or researchers. CDM ensures that collected data during a trial is complete correct, consistent and valid.
- Clinical Data Management is the process of collection, integration and validation of clinical trial data and it is the process of ensuring that data collected during a clinical trial is accurate, complete, logical and consistent.
- CDM plays an essential role in the data collection phase of clinical research, the process of collecting and managing research data is done in accordance with regulatory standards to obtain quality information that is complete and error-free. The goal is to gather as much of data as possible per analysis for the regulatory submission
Overview of Clinical Data Management Training:
The Clinical data manager plays a very important role in three major areas. These are study setup, this includes all the activities that are done before at the start of the study. Study Conduct starts once a subject enrollment begins or with the first patient first visit. Study Closeout, at this step the data is final and ready for statistical analysis in terms of time and effort. Study setup takes about 15% of the time and effort followed by study conduct which takes about 60% of the time and effort followed by Study Closeout which takes about 25% of the time and effort. Study Conduct and Closeout activities overlap due to ongoing subject enrollment and corresponding case report from lock. Let us discuss this setup in detail.
What is adverse advent? Adverse events are also known as side effects and these side effects could be due to administering that experimental drug. Who is a Clinical research associate? The person who is employed by the study sponsor to monitor a clinical trial. The CRA is responsible for ensuring all clinical studies that are conducted according to the study protocol and ICH guidelines.
Study Setup:
It includes activities but not limited to such as preparing data management plan, Case Report Form(CRF) annotation, Database build and design, Edit check or Validation rule implementation, UAT(User Acceptance Testing).
Study conduct:
It includes ensuring that data is collected, validated, complete and consistent. Central laboratory or third party data transfer, data coding, using Medra and WHODDE dictionaries, Query Management, SAE reconciliation and reports generation or matrix and tracking.
Study Closeout:
It includes but or not limited to ensuring all data management activities are complete, Database lock, Electronic Archival and database transfer. There could be more or less activities associated with each setup depending on the organisation protocol or phase of the study.
Features of Clinical Data Management Training:
- There are many software tools available for Data management and these are called as clinical Data management systems. Most of the CDM systems used in pharmaceutical companies are commercial. But a few open source tools are available. The commonly used commercial CDM tools are RAVE, Oracle Clinical, Inform, Clinical trial and Custom CDMS as some of the pharmaceutical companies use their own custom made tools.
- These CDMS tools are helpful in maintaining the audit trial of data management activities, audit trial tracks all the details related to all kinds of discrepancies and the changes done. Now these high quality data cannot be felicitated without following certain rules and regulations, standards. As we all know pharmaceutical companies depend on electronic mode for data management in a clinical trial. So it is important for them to follow good practice in CDM and maintain the record standards in Electronic Data capture.
- These electronic records have to comply with a code of federal regulations 21CFR part11. This enables the employment of validated systems to achieve correct, reliable, and consistent data. Idestrainings is best in providing Clinical Data Management Training by industry experts from India.
Interchange Standards Consortium of Clinical Data Management Training:
- It is a multi-disciplinary non-profit organisations which has developed standards to support acquisition, exchange, submission and archival of clinical research data and metadata. Metadata is data of the data entered such as data about the individual who meet the change in the clinical data.
- SDTMIG describes the details of model and standard terminologies for the data and serves as a guide to the organisation and CDASH which is available free of cost from the CDISC website defines the basic standards for the collection of data in a clinical trial and enlists the basic data information needed from a clinical regulatory and scientific perspective.
- Society for Clinical Data Management (SCDM) provides the Good Clinical Data Management Practices guidelines (GCDMP). Clinical Trial has 4 phases, and for each phase Data needs to be submit it to the Revolutionary authorities.
Glossary of Clinical Trials in Clinical Data Management Training:
CRO is basically a company that helps conducting research for a sponsor company, what you must be thinking is why does a sponsor company need a CRO to conduct its research? CRO specializes in conducting research compared to pharmaceutical companies. It also helps the sponsor company by saving cost and helping reducing the time period required to conduct the clinical trials. Are you passionate in doing certifications? Idestrainings is best in providing Clinical Data Management Certification training by real time experts.
What is Informed Consent?
- It’s nothing but verification of a person’s willingness to participate in a research prior to enrollment into a clinical trial researchers inform participants about all relevant details, participants will be given informed consent document that details all the important study information. For example purpose of trial, duration of the trials, risks involved in the trial, potential benefits and then they will be asked to sign this document if they agree to participate in that trial.
- They are going to sign that document, inform consent document it’s not a contract who participate in the clinical trial is voluntary and the patient may withdraw from the trial at any time. Institutional review board IRB what is IRB? It ensures that clinical trial is ethical and rights of study participants are protected.
- Now what is Risk Benefit analysis? Analysis which focuses not just on the risks of the activity but also on the benefits of the activity. To determine whether research should be completed or not moving to next slide. Who is a subject, we all know what does a patient is but in terms of Clinical research terminology a individual seeking medical care we also known as subject.
- What is protocol? A protocol is the study plan on which a clinical trial is based. It describes what type of people may participate in the trial in SAS Clinical Training. The schedule of tests to be conducted in the trial processors to be undergone example medications, dosages and length of the study everything will be given in detail in this protocol.
- It’s data records on which clinical observations are first recorded for example it can be assigned inform consent forms, any hospital records, laboratory reports. What is case report form? There are two types of case report forms paper and electronic. Sponsor of the clinical trial uses CRF to collect data from each patient.
Clinical Trial Process in Clinical Data Management Training:
- It begins with pre clinical testing, what is Preclinical testing? Preclinical testing conducted in animals it’s a stage of research that begins before clinical trials can begin, performed on animals and these are required before clinical trials in human can be started while pre clinical research usually provides some general information about dosing. We are best in providing Clinical Data Management Training with live projects by real time experts.
- So sponsors or drug developers must submit iron D. Investigational new drug application to health authorities such as FDA Food Drug Administration USFDA. Before beginning Clinical research trials can start once approval is granted. Now we will discuss about Investigational new drug application. It’s nothing but a petition through which a drug sponsor requests the FDA to allow human testing of a new drug, once it is filed and approval is granted then sponsor starts phase1 , phase2, phase3 and six phases new drug application.
- What is new drug application? An application submitted by a sponsor to the FDA for approval to market a new drug for human use. So one sponsor some files NDA and gets approval then commences phase4.
- In phase1, it generally conducted in several months from 20 to 80 people around are going to be participated in the phase1 trial and this phase1 trial tells about side effects finding out about side effects and what happens to the treatment in the body.
- In phase 2 trial we generally call as safety and dosing phase several months to two years is the period which it occurs 100 to 300 participants. And it says more about side effects finding out more about side effects and effectiveness and looking at how well the treatment is working
- Phase3 trial is which safety and efficacy will be assessed and the ratio of the participants is 300 to 3000 participants, it compares the new treatment to the standard treatment. In phase4, it tells more about long term benefits and side effects. It is finding out more long-term benefits and side effects.
Conclusion of Clinical Data Management Training :
What’s the bottom line? In Clinical trial a huge amount of data is generated which is known as clinical data, proper management of clinical data is very important in a clinical trial because these data are the based for approval of any investigational product by Regulatory Authority. We are rich in providing CDM Online Training by real time experts at flexible timings. So what are you waiting for? Join in Idestrainings for best Clinical Data Management Training by experts from India. Hurry Up!