Clinical Research Interview Question Part 4

Embark on a comprehensive journey into the dynamic and critical realm of Clinical Research. This presentation serves as a guiding beacon for both novices and seasoned professionals, shedding light on the intricacies, significance, and evolving landscape of clinical research in advancing medical knowledge and improving patient outcomes.

1. Interview Preparation Questions CLINICAL RESEARCH PART-4 www.clinosol.com | 9121151622| @clinosolresearch

2. 1 2 3 4 5 What is Essential Document? Who is Investigator? What is Monitoring? What is Randomization and Types of Randomization? INDEX www.clinosol.com | 9121151622| @clinosolresearch What is Source Document?

3. www.clinosol.com | 9121151622| @clinosolresearch Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compilance of the Investigator, Sponser and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. Essential Documents are classified into 3 different types: Before start of CT During the conduct of CT After the conduct of CT What is Essential Document?

4. www.clinosol.com | 9121151622| @clinosolresearch Who is Investigator? A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. Investigator’s Responsibilities Investigator’s Qualifications and Agreements Adequate Resources Medicalcare of Trial subjects Communication with IRB/IEC Compliance with protocol Investigational product Informed consent of Trialsubjects Records and Reports

5. www.clinosol.com | 9121151622| @clinosolresearch •The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol,Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements. •Monitor acts as main line of communication between sponsor and investigator. At least 3 Monitoring visits: Before start of the trial Duringthetrial Afterthetrial What is Monitoring?

6. www.clinosol.com | 9121151622| @clinosolresearch What is Randomization? Randomly assigning subjects to the treatment group based on element of chance is called Randomization. Randomization is done to avoid bias. Types of randomization Simple randomization: In simple randomization, the subjects are randomly allocated to experiment/intervention groups based on a constant probability. The advantage is that it eliminates selection bias. Block randomization: In block randomization, the subjects of similar characteristics are classified into blocks.The aim of block randomization is to balance the number of subjecs allocated to each experiment/intervention group. Stratified randomization: In stratified randomization,the subjects are defined based on certain strata,which are covariates. The advantage of this methodology is that it enables comparability between experiment/interventiongroupsandthus makes result analysis more efficient.

7. www.clinosol.com | 9121151622| @clinosolresearch Original records or documents which shows the evidence about methods and evaluation of results. (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records keptat thepharmacy,atthelaboratories andat medico- technicaldepartmentsinvolved in the clinicaltrial). What is Source Document?

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9. Acheivements-2023

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