Sanofi
60+ Luthra Group Company Interview Questions and Answers
Q1. How many Indians have health insurance? What percent of them use health insurance for conservative treatment solutions?
The number of Indians with health insurance and the percentage using it for conservative treatment solutions is not available.
Data on the number of Indians with health insurance is not available.
Data on the percentage of Indians using health insurance for conservative treatment solutions is not available.
No specific examples or statistics can be provided without the available data.
Q2. What is the current scenario of the pharma market in India?
The pharma market in India is growing rapidly with increasing demand for healthcare products and a favorable regulatory environment.
The Indian pharmaceutical market is one of the largest in the world, valued at over $20 billion.
The market is expected to grow at a CAGR of 15.92% from 2020 to 2025.
India is a major exporter of generic drugs and supplies a significant portion of the global demand.
The government's initiatives like 'Make in India' and 'Pharma Vision 2020' have boos...read more
Q3. What are the steps you follow to write a manuscript from scratch?
Steps to write a manuscript from scratch
Define the research question and hypothesis
Conduct literature review and gather data
Organize data and create an outline
Write the introduction, methods, results, and discussion sections
Edit and revise the manuscript
Submit to a journal for peer review
Incorporate feedback and make final revisions
Q4. How different are Pharma and Healthcare as business functions?
Pharma and Healthcare are distinct business functions with different focuses and objectives.
Pharma primarily deals with the research, development, and production of drugs and medications.
Healthcare encompasses a broader range of services including medical treatment, diagnostics, preventive care, and patient care.
Pharma companies focus on developing and marketing pharmaceutical products to healthcare providers and consumers.
Healthcare organizations provide direct patient care,...read more
Q5. How are the Healthcare and Pharmaceuticals markets different?
Healthcare and Pharmaceuticals markets differ in terms of products, regulations, and target customers.
Healthcare market focuses on providing medical services and care to patients.
Pharmaceutical market involves the development, production, and sale of drugs and medications.
Healthcare market includes hospitals, clinics, and healthcare providers.
Pharmaceutical market includes pharmaceutical companies and drug manufacturers.
Healthcare market is regulated by government bodies to e...read more
Q6. What population in India has health insurance and on which cases are they willing to use?
A significant portion of the population in India has health insurance, and they are willing to use it for various medical cases.
A large number of people in India have health insurance coverage.
They are willing to use their health insurance for hospitalization expenses.
Health insurance is also used for outpatient treatments and consultations.
People often utilize health insurance for surgeries and medical procedures.
Insurance coverage is commonly used for medication and prescri...read more
Q7. Challenges that a typical pharmaceutical company face from sales and marketing POV in India wrt abroad.
Pharmaceutical companies in India face challenges in sales and marketing compared to abroad.
Stringent regulations and complex approval processes in India
Intense competition from local and international pharmaceutical companies
Price control policies and government regulations affecting profit margins
Diverse and fragmented market with varying healthcare infrastructure
Lack of awareness and trust in generic drugs
Counterfeit drugs and illegal parallel imports
Language and cultural ...read more
Q8. Types of sterilization techniques And differences between dry heat sterilization & moist heat sterilization?
There are two types of sterilization techniques: dry heat and moist heat. Dry heat uses high temperatures while moist heat uses steam.
Dry heat sterilization uses high temperatures ranging from 160-180°C for 2-4 hours.
Moist heat sterilization uses steam at a temperature of 121°C for 15-20 minutes.
Dry heat sterilization is suitable for materials that can withstand high temperatures such as glassware, metal instruments, and powders.
Moist heat sterilization is suitable for materi...read more
Q9. What guidelines do you follow to write a manuscript?
Guidelines for writing a manuscript
Identify the target audience and purpose of the manuscript
Follow the structure of IMRAD (Introduction, Methods, Results, and Discussion)
Use clear and concise language, avoiding jargon and unnecessary technical terms
Cite relevant literature and provide evidence to support claims
Ensure accuracy and consistency of data and formatting
Proofread and edit multiple times for grammar, spelling, and punctuation errors
Q10. How to communicate the risk factors to different stake holders and how to track the risk mitigation actions
Risk factors can be communicated to stakeholders through clear and concise reports and meetings. Tracking can be done through regular updates and documentation.
Create a risk assessment report that outlines the potential risks and their impact on the project or organization
Schedule meetings with stakeholders to discuss the risks and potential mitigation strategies
Provide regular updates on the progress of risk mitigation actions
Document all risk mitigation actions and their ou...read more
Q11. Do research and present the current OA scenario in India.
Open Access (OA) scenario in India
India has seen a significant growth in OA initiatives in recent years
Several government-funded research institutions have adopted OA policies
Indian Council of Agricultural Research (ICAR) mandates OA for agricultural research
OA repositories like Indian Academy of Sciences, National Digital Library, etc. promote OA content
Some Indian journals have transitioned to OA models, such as the Indian Journal of Medical Research
OA awareness and advocac...read more
Q12. Estimate the total number of Knee replacement surgeries taking place in India?
The total number of knee replacement surgeries in India is difficult to estimate accurately.
The number of knee replacement surgeries in India can vary each year due to factors such as population growth, aging population, and advancements in medical technology.
To estimate the total number, we can consider the average number of knee replacement surgeries performed in major hospitals and multiply it by the total number of hospitals in India.
Government data and statistics from me...read more
Q13. Guidelines for Quality Risk Management and the steps in Quality Risk Management
Quality risk management involves guidelines and steps to identify, assess, and mitigate risks in order to ensure quality in systems and processes.
Guidelines for quality risk management include following regulatory requirements and industry standards
Steps in quality risk management include risk identification, risk assessment, risk control, and risk review
Risk identification involves identifying potential risks that may impact quality
Risk assessment involves evaluating the sev...read more
Q14. What are the different stages in clinical trials?
Clinical trials involve several stages to test the safety and effectiveness of new treatments.
Phase 0: Exploratory study to determine how a drug is metabolized in the body.
Phase 1: Small-scale study to assess the safety and dosage range of a new treatment.
Phase 2: Larger study to evaluate the effectiveness and side effects of the treatment.
Phase 3: Extensive study to confirm the treatment's benefits, monitor side effects, and compare it to existing treatments.
Phase 4: Post-ma...read more
Q15. Estimate the number of knee replacement surgeries in India.
The number of knee replacement surgeries in India can be estimated based on population demographics, prevalence of knee-related conditions, and healthcare infrastructure.
Estimation can be done by considering the population size and age distribution in India.
The prevalence of knee-related conditions like osteoarthritis and rheumatoid arthritis can be taken into account.
The availability and accessibility of healthcare facilities specializing in knee replacement surgeries.
Data f...read more
Q16. What do you know about GPP?
GPP stands for Good Publication Practice.
GPP is a set of guidelines for the ethical and transparent publication of research in the medical and scientific fields.
It provides recommendations on authorship, data integrity, conflicts of interest, and disclosure of funding sources.
GPP ensures that publications are accurate, reliable, and unbiased.
Examples of GPP guidelines include the International Committee of Medical Journal Editors (ICMJE) guidelines and the Good Publication Pr...read more
Q17. Tell me about Bacterial endotoxin test?
Bacterial endotoxin test is a test used to detect the presence of endotoxins in pharmaceutical products.
It is a test used to ensure the safety of pharmaceutical products.
It detects the presence of endotoxins, which are harmful substances produced by certain bacteria.
The test is performed using a sample of the product and a reagent that reacts with endotoxins.
The result is measured using a spectrophotometer or other analytical instrument.
The test is required by regulatory agen...read more
Q18. process explaining the proposal of risk mitigation and risk acceptance after attainment of residual risk
After attaining residual risk, propose risk mitigation and acceptance process.
Evaluate the residual risk and identify potential risk mitigation strategies
Assess the feasibility and effectiveness of each strategy
Prioritize the strategies based on their impact and feasibility
Implement the selected strategies and monitor their effectiveness
If residual risk is still present, determine if it is acceptable based on risk tolerance and regulatory requirements
Document the risk mitigat...read more
Q19. How to proceed with any projects?
Q20. Why marketing and strategy?
Marketing and strategy are essential for business success as they help in understanding customer needs, creating competitive advantage, and driving growth.
Marketing helps in identifying customer needs and preferences.
Strategy helps in creating a roadmap for achieving business goals.
Marketing and strategy work together to create a competitive advantage.
They help in targeting the right audience and positioning products/services effectively.
Marketing and strategy drive growth by...read more
Q21. Give us an overview of the pharma market in India.
The pharma market in India is one of the largest in the world, with a strong domestic industry and growing exports.
India is the third-largest pharmaceutical market globally.
The industry is dominated by generic drugs, which account for a significant share of the market.
The market is highly competitive, with both domestic and multinational companies operating.
Government initiatives like 'Make in India' and 'Pharma Vision 2020' aim to boost domestic manufacturing and research ca...read more
Q22. Equipment Used in Microbiology laboratory And their uses?
Equipment used in microbiology lab and their uses
Microscope - to observe microorganisms
Incubator - to grow and maintain cultures at a specific temperature
Autoclave - to sterilize equipment and media
Bunsen burner - to sterilize inoculating loops and needles
Laminar flow hood - to maintain a sterile environment for handling samples
pH meter - to measure the acidity or alkalinity of a solution
Colony counter - to count and record bacterial colonies on agar plates
Spectrophotometer -...read more
Q23. What is the package for annum??
The package for annum refers to the unit of time equal to one year.
Annum is a Latin term meaning 'year'.
In the context of chemistry, the package for annum is used to express rates or frequencies over a period of one year.
For example, the decay rate of a radioactive substance may be measured in disintegrations per annum.
Q24. How do you prepare culture Media?
Culture media preparation involves sterilization, mixing of ingredients, and pH adjustment.
Sterilize all equipment and ingredients before use
Mix ingredients according to recipe or manufacturer instructions
Adjust pH as necessary using acid or base solutions
Autoclave or sterilize the final product before use
Examples of culture media include nutrient agar, blood agar, and MacConkey agar
Q25. Tell more about randomization, sample size and other statistical method which you have used
Randomization, sample size, and other statistical methods are crucial in ensuring the validity and reliability of study results.
Randomization helps in reducing bias by ensuring that each participant has an equal chance of being assigned to different treatment groups.
Sample size calculation is important for determining the number of participants needed to detect a meaningful difference between groups with a certain level of confidence.
Statistical methods such as regression ana...read more
Q26. Genetically modified microorganisms' examples?
Genetically modified microorganisms are organisms whose genetic material has been altered using genetic engineering techniques.
Bt corn, which produces a protein toxic to certain insects
Golden rice, which is engineered to produce beta-carotene
Yeast engineered to produce insulin
E. coli bacteria engineered to produce human growth hormone
Q27. 1.What is impact factor 2.What are the sources of downloading articles 3. What are the therapeutic areas you have worked on 4. reason for switch
Impact factor is a measure of the frequency with which the average article in a journal has been cited in a particular year.
Impact factor is calculated by dividing the number of citations in the current year to articles published in the previous two years by the total number of articles published in the previous two years.
Higher impact factor indicates greater influence and prestige of the journal.
Sources of downloading articles include academic databases like PubMed, Google ...read more
Q28. What is the water system processing sand filter and clorien
The water system processes sand filter to remove impurities and chlorine to disinfect the water.
Sand filter is used to remove particles and impurities from the water.
Chlorine is added to disinfect the water and kill harmful bacteria.
Sand filters can be backwashed to clean and maintain their effectiveness.
Chlorine levels need to be monitored regularly to ensure proper disinfection.
The water system may also use other treatment processes in addition to sand filtration and chlori...read more
Q29. Are u handled QMS if yes then tell me in brief
Yes, I have handled QMS. It stands for Quality Management System.
QMS is a set of policies, processes, and procedures used to ensure that an organization delivers quality products or services consistently.
I have experience in implementing QMS in my previous role as an Executive Assistant Manager.
I have also conducted internal audits to ensure compliance with QMS standards.
One example of a QMS standard is ISO 9001, which focuses on customer satisfaction and continuous improveme...read more
Q30. Gram staining technique and mechanism?
Gram staining is a laboratory technique used to differentiate bacterial species into two groups based on their cell wall composition.
Developed by Danish bacteriologist Hans Christian Gram in 1884
Involves staining bacterial cells with crystal violet and iodine, then washing with alcohol and counterstaining with safranin
Gram-positive bacteria retain the crystal violet stain and appear purple under a microscope, while gram-negative bacteria lose the stain and appear pink or red
U...read more
Q31. Maintaing of pm periodical data
Maintaining PM periodical data involves tracking and scheduling preventive maintenance tasks to ensure equipment efficiency.
Create a schedule for routine maintenance tasks such as filter replacements, coil cleaning, and system inspections
Record all maintenance activities in a log or database for easy reference
Track equipment performance and identify any trends or issues that may require attention
Regularly review and update the PM schedule to ensure all tasks are completed on ...read more
Q32. how does vaccination work?
Vaccination works by introducing a weakened or inactive form of a pathogen into the body to stimulate the immune system to produce antibodies.
Vaccines contain either weakened or inactive forms of a virus or bacteria
When the vaccine is administered, the immune system recognizes the pathogen as foreign and produces antibodies to fight it
These antibodies remain in the body, providing immunity if the person is exposed to the actual pathogen in the future
Q33. What is CRISPR technology?
CRISPR technology is a revolutionary gene-editing tool that allows scientists to make precise changes to an organism's DNA.
CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats
It uses a protein called Cas9 to cut DNA at specific locations
CRISPR technology has a wide range of applications, from correcting genetic disorders to creating genetically modified organisms
Q34. All water system line modification
Water system line modification involves changes to the piping network for improved efficiency and functionality.
Identify areas of the water system that require modification
Develop a plan for the modification process
Ensure compliance with safety and regulatory standards
Implement the modifications and test the system for functionality
Monitor the system for any issues post-modification
Q35. How can you make a difference for patient safety?
I can make a difference for patient safety by implementing robust pharmacovigilance processes, conducting thorough risk assessments, and ensuring timely reporting of adverse events.
Implementing robust pharmacovigilance processes to monitor and evaluate the safety of medications
Conducting thorough risk assessments to identify potential safety concerns and mitigate risks
Ensuring timely reporting of adverse events to regulatory authorities to take appropriate actions
Collaboratin...read more
Q36. QMS activities and their significance in industry.
Q37. What types of documents did o have experience managing
I have experience managing a variety of documents including clinical trial protocols, regulatory submissions, medical manuscripts, and patient education materials.
Clinical trial protocols
Regulatory submissions
Medical manuscripts
Patient education materials
Q38. Tell me about Bioburden test?
Bioburden test is a method to measure the number of microorganisms present on a surface or in a sample.
It is used to ensure the cleanliness and sterility of medical devices and pharmaceutical products.
The test involves taking a sample from the product or surface and culturing it in a nutrient-rich environment to encourage the growth of microorganisms.
The number of colonies that grow is then counted and used to determine the bioburden of the sample.
The results of the test are ...read more
Q39. Explain End to end study which you have done?
I led a comprehensive study on the effectiveness of a new drug in treating diabetes from data collection to analysis and reporting.
Designed the study protocol and statistical analysis plan
Conducted sample size calculation and randomization
Performed data cleaning, analysis, and interpretation
Presented findings to stakeholders and regulatory authorities
Published results in a peer-reviewed journal
Q40. process flow of QRM and personality test
QRM process flow involves identification, assessment, control, and review of risks. Personality tests help in identifying individual traits.
QRM process flow includes identifying potential risks, assessing their impact, implementing control measures, and reviewing the effectiveness of the controls.
Personality tests can be used to identify individual traits such as risk-taking behavior, attention to detail, and communication skills.
The results of personality tests can be used t...read more
Q41. All system sampling protocol
System sampling protocol refers to the process of collecting and analyzing data from various systems to ensure their proper functioning.
Identify the systems that need to be sampled
Determine the frequency and duration of sampling
Establish the sampling method and equipment
Collect and analyze the data
Take corrective action if necessary
Q42. Current CTC:8lacs per year
My current CTC is 8lacs per year.
My current annual salary is 8lacs.
I am currently earning 8lacs per year.
My current CTC stands at 8lacs annually.
Q43. How will you manage sales performance
I will manage sales performance by setting clear goals, providing training and support to the team, analyzing data regularly, and adjusting strategies as needed.
Set clear and achievable sales goals for the team
Provide ongoing training and support to improve sales skills
Regularly analyze sales data to identify trends and areas for improvement
Adjust sales strategies based on performance data and market conditions
Q44. What is different type of packaging
Packaging can be classified into primary, secondary, tertiary, and quaternary types.
Primary packaging is the material that directly contains the product, like a bottle for a soft drink.
Secondary packaging is used to group primary packages together, like a cardboard box for multiple bottles.
Tertiary packaging is used for transportation and storage, like a pallet or shrink wrap.
Quaternary packaging is used for handling and distribution, like a container for multiple pallets.
Q45. M G F Fliter cleaning how to do you
Cleaning MGF filters involves backwashing, rinsing, and disinfecting to remove accumulated debris and ensure proper filtration.
Backwash the filter to remove accumulated debris and dirt
Rinse the filter thoroughly to ensure all debris is removed
Disinfect the filter to kill any remaining bacteria or contaminants
Regular maintenance and cleaning schedule is important to ensure optimal filter performance
Q46. All system leakages
System leakages are a critical issue that needs to be addressed immediately.
System leakages can cause damage to equipment and pose safety risks to personnel.
Regular inspections and maintenance can help prevent system leakages.
Common causes of system leakages include corrosion, wear and tear, and improper installation.
Leak detection systems can be installed to quickly identify and address any leaks.
Proper training and education for personnel can also help prevent system leakag...read more
Q47. Explain about market compliance with a case study
Market compliance ensures products meet legal requirements and industry standards.
Market compliance involves ensuring products meet legal requirements and industry standards
Case study: Company X faced fines for selling products that did not meet safety regulations
Market compliance may involve conducting regular audits and inspections to ensure adherence to regulations
Market compliance can impact a company's reputation and bottom line
Q48. What items were covered in SOX Reports
SOX Reports cover items related to internal controls, financial reporting, and compliance.
Internal controls implemented by the company
Financial reporting processes and accuracy
Compliance with regulations and laws
Documentation of processes and controls
Testing of controls and reporting on any deficiencies
Q49. Difference between List and Tuple?
List is mutable, Tuple is immutable in Python.
List can be modified after creation, Tuple cannot be modified
List is defined using square brackets [], Tuple is defined using parentheses ()
Example: list_example = [1, 2, 3], tuple_example = (4, 5, 6)
Q50. Define a sales forecasting approach?
Sales forecasting approach is a method used to predict future sales based on historical data and market trends.
Sales forecasting can be done using quantitative methods like time series analysis or qualitative methods like expert opinion.
It involves analyzing past sales data, market trends, and other relevant factors to predict future sales.
Different approaches include moving average method, exponential smoothing, regression analysis, and market research.
Sales forecasting help...read more
Q51. 4. IOQ's Execution procedures
IOQ's execution procedures ensure proper installation and operation of equipment.
IOQ stands for Installation, Operational, and Performance Qualification
Execution procedures involve testing and verifying equipment performance
Documentation is crucial for IOQ procedures
Examples of IOQ procedures include verifying temperature and pressure readings on a HVAC system
IOQ procedures are important for ensuring equipment meets regulatory requirements
Q52. Tell me about survival analysis
Survival analysis is a statistical method used to analyze the time until an event of interest occurs.
It is commonly used in medical research to study the time until death or recurrence of a disease.
Survival analysis takes into account censored data, where the event of interest has not yet occurred for some individuals.
Kaplan-Meier curves and Cox proportional hazards models are commonly used techniques in survival analysis.
It can also be used in other fields such as engineerin...read more
Q53. Have you make any Down payment
Yes, I have made a down payment on my car loan.
Yes, I made a down payment of 20% on my car loan.
The down payment helped lower my monthly payments.
I saved up for the down payment over several months.
Q54. How will you foresee risks?
I will foresee risks by conducting thorough risk assessments and utilizing past project data.
Conducting thorough risk assessments to identify potential risks
Analyzing past project data to identify common risks and patterns
Consulting with team members and stakeholders to gather insights on potential risks
Monitoring industry trends and best practices to anticipate emerging risks
Implementing risk mitigation strategies and contingency plans
Q55. What is carb counting?
Carb counting is a method of tracking the amount of carbohydrates in food to manage blood sugar levels.
Carb counting involves identifying the total amount of carbohydrates in a meal or snack.
It helps people with diabetes to adjust their insulin doses and maintain blood sugar levels.
Carb counting can be done manually or with the help of apps and tools.
For example, a medium-sized apple contains around 25 grams of carbohydrates.
Carb counting is an important part of diabetes mana...read more
Q56. How will you handle bias
I will address bias by promoting diversity, providing training on unconscious bias, and creating a culture of inclusion.
Promote diversity in hiring and decision-making processes
Provide training on unconscious bias for all employees
Create a culture of inclusion where all voices are heard and valued
Q57. What is ur expected CTC
My expected CTC is based on my experience, skills, and the industry standards.
My expected CTC is in line with the market rates for Quality Assurance Specialists.
I have taken into consideration my years of experience in the field.
I have also factored in any additional certifications or qualifications that I possess.
I am open to negotiation based on the overall compensation package offered by the company.
Q58. 2.GDP and cGMP procedures.
GDP and cGMP are procedures related to quality control in manufacturing.
GDP stands for Good Distribution Practice and is related to the proper distribution of pharmaceutical products.
cGMP stands for Current Good Manufacturing Practice and is related to the manufacturing process of pharmaceutical products.
Both GDP and cGMP are important for ensuring the quality, safety, and efficacy of pharmaceutical products.
GDP guidelines cover areas such as storage, transportation, and docu...read more
Q59. WFI sanitisation what is parpose
WFI sanitisation is essential to maintain the quality and purity of Water for Injection used in pharmaceutical manufacturing.
WFI sanitisation is done to ensure that the water meets the required quality standards for use in pharmaceutical manufacturing processes.
It involves the removal of impurities, microorganisms, and endotoxins from the water to prevent contamination of the final product.
Sanitisation methods may include filtration, UV treatment, and chemical disinfection.
Re...read more
Q60. How to write code in LIMS
Writing code in LIMS involves creating scripts to automate processes, customize workflows, and integrate with other systems.
Understand the LIMS platform and its scripting capabilities
Use the appropriate programming language supported by the LIMS system (e.g. Python, Java)
Follow best practices for coding such as commenting, version control, and testing
Utilize LIMS APIs for data retrieval and manipulation
Collaborate with domain experts to ensure code meets requirements
Q61. Explain about supplier qualification
Supplier qualification is the process of evaluating and approving potential suppliers based on criteria such as quality, reliability, and compliance.
Supplier qualification involves assessing suppliers' capabilities, quality management systems, and adherence to regulations.
Criteria for supplier qualification may include financial stability, production capacity, and past performance.
Supplier audits and site visits are often conducted to verify compliance with quality standards ...read more
Q62. What is tablet tooling
Tablet tooling refers to the process of creating tablets using specialized tooling equipment.
Tablet tooling involves the use of punches and dies to compress powdered ingredients into tablets.
The tooling equipment must be precise to ensure uniform tablet size and weight.
Different shapes and sizes of tablets can be produced using different tooling configurations.
Examples of tablet tooling equipment include rotary tablet presses and single-punch tablet presses.
Q63. What is diabetes?
Diabetes is a chronic condition that affects how your body processes blood sugar (glucose).
Diabetes occurs when the pancreas doesn't produce enough insulin or the body can't effectively use the insulin it produces.
There are two main types of diabetes: type 1 and type 2.
Symptoms of diabetes include increased thirst, frequent urination, blurred vision, and fatigue.
Diabetes can lead to serious complications such as heart disease, kidney damage, and nerve damage.
Treatment for dia...read more
Q64. Golden rules of account
Golden rules of accounting are basic principles to be followed while maintaining accounts.
Debit the receiver, credit the giver
Debit what comes in, credit what goes out
Debit all expenses and losses, credit all incomes and gains
Q65. Type of paking machines
There are various types of packing machines available depending on the product and packaging requirements.
Vertical form fill seal machines for packaging granular products like coffee, sugar, etc.
Horizontal form fill seal machines for packaging products like biscuits, chocolates, etc.
Vacuum packaging machines for extending the shelf life of products like meat, fish, etc.
Shrink wrapping machines for packaging products like bottles, cans, etc.
Cartoning machines for packaging pro...read more
Q66. Process of tablet formualtion
Tablet formulation involves blending active pharmaceutical ingredients with excipients, granulating, compressing, and coating to create a solid dosage form.
Blend active pharmaceutical ingredients with excipients
Granulate the mixture to form granules
Compress the granules into tablets
Coat the tablets for protection or taste masking
Q67. Explain about SAP
SAP stands for Statistical Analysis Plan, which outlines the statistical methods to be used in a clinical trial or research study.
SAP is a crucial document in clinical research, detailing the statistical methods, data handling, and analysis procedures.
It includes information on study design, sample size calculation, randomization, statistical tests, and data interpretation.
The SAP is developed before the study begins to ensure transparency and consistency in data analysis.
It ...read more
Q68. ICMJE guidelines
ICMJE guidelines are a set of recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals.
ICMJE stands for International Committee of Medical Journal Editors
The guidelines cover topics such as authorship, conflicts of interest, and data sharing
Authors submitting manuscripts to medical journals are expected to adhere to these guidelines
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