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Understanding Clinical Trial Study Designs: A Comprehensive Overview

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Clinical trials are the backbone of medical research, providing the necessary data to determine the safety and efficacy of new treatments, drugs, or interventions. A well-structured clinical trial design is crucial to generating reliable and valid results. Understanding the different types of study designs is essential for anyone involved in clinical research, whether they are healthcare professionals, researchers, or patients. This article delves into the various clinical trial study designs, highlighting their strengths, limitations, and applications. 1. Randomized Controlled Trials (RCTs) Overview:Randomized Controlled Trials (RCTs) are considered the gold standard in clinical research. In an RCT, participants are randomly assigned to either the treatment group or the control group. The treatment group receives the intervention under investigation, while the control group may receive a placebo, standard treatment, or no treatment at all. Strengths: Limitations: Applications:RCTs are used extensively in testing new drugs, medical devices, and therapeutic interventions. 2. Cohort Studies Overview:Cohort studies involve following a group of people (cohort) over time to observe how certain exposures or interventions affect outcomes. These can be either prospective (looking forward in time) or retrospective (looking back at existing data). Strengths: Limitations: Applications:Cohort studies are often used in epidemiology to study the causes of diseases, as well as in long-term health outcome research. 3. Case-Control Studies Overview:In a case-control study, researchers start with an outcome (such as a disease) and work backward to investigate the exposure that might have led to it. Participants are divided into two groups: cases (those with the outcome) and controls (those without the outcome). Strengths: Limitations: Applications:Case-control studies are often used in epidemiology to identify factors that may contribute to a medical condition. 4. Cross-Sectional Studies Overview:Cross-sectional studies analyze data from a population at a single point in time. Researchers look at the prevalence of outcomes and exposures simultaneously. Strengths: Limitations: Applications:Cross-sectional studies are often used in public health to assess the prevalence of diseases and risk factors in a population. 5. Crossover Studies Overview:In a crossover study, participants receive multiple interventions in a random order, with a washout period in between to eliminate the effects of the previous treatment. Each participant serves as their own control. Strengths: Limitations: Applications:Crossover studies are commonly used in pharmacokinetic research, where the goal is to compare the effects of different drugs or dosages in the same individuals. 6. Adaptive Clinical Trials Overview:Adaptive clinical trials are designed to allow modifications to the trial procedures (e.g., sample size, treatment arms) based on interim results. These trials are more flexible and efficient than traditional fixed-design trials. Strengths: Limitations: Applications:Adaptive trials are increasingly used in drug development, particularly in oncology, where the need for rapid innovation is high. Conclusion Each clinical trial study design serves a unique purpose and has its own set of strengths and limitations. The choice of design depends on various factors, including the research question, the nature of the intervention, ethical considerations, and available resources. Understanding these designs is crucial for conducting rigorous and reliable clinical research that can lead to meaningful advancements in healthcare. This overview provides a foundational understanding of the most common clinical trial designs, helping researchers, healthcare professionals, and stakeholders make informed decisions in the pursuit of better treatments and outcomes.

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Navigating the Multifaceted World of Clinical Trials: Essential Skills for Each Department

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Clinical trials are complex endeavors that require the collaboration of various departments, each with specialized skills and expertise. These departments work synergistically to ensure the safe, ethical, and effective conduct of trials. Below, we delve into the essential skills required for key departments involved in clinical trials. 1. Clinical Operations Clinical Operations is the backbone of clinical trials, managing the day-to-day activities to ensure the trial runs smoothly. Essential Skills: 2. Clinical Data Management This department is responsible for collecting, processing, and ensuring the integrity of trial data. Essential Skills: 3. Biostatistics Biostatisticians play a crucial role in designing the trial and analyzing the data to draw meaningful conclusions. Essential Skills: 4. Clinical Monitoring Clinical monitors ensure the trial is conducted according to the protocol and regulatory requirements. Essential Skills: 5. Medical Writing Medical writers produce the documentation necessary for regulatory submissions and publication. Essential Skills: 6. Regulatory Affairs This department ensures that the trial complies with all regulatory requirements. Essential Skills: 7. Quality Assurance Quality Assurance ensures that all trial activities adhere to SOPs (Standard Operating Procedures) and regulatory standards. Essential Skills: 8. Clinical Pharmacology This team studies the effects, mechanisms, and metabolism of the investigational product. Essential Skills: 9. Ethics and Compliance This department ensures that the trial adheres to ethical standards and protects participant rights. Essential Skills: 10. Investigator Site Management The investigators and their teams at the trial sites are crucial for executing the trial protocol. Essential Skills: Conclusion Each department in clinical trials plays a vital role and requires a unique set of skills to contribute effectively to the trial’s success. Mastery of these skills ensures that clinical trials are conducted efficiently, ethically, and in compliance with regulatory standards, ultimately leading to the development of safe and effective medical treatments.

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Regulatory Affairs-Interview Questions & Answers

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Regulatory Affairs in the Pharmaceutical industry is a profession that acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing. What are the goals of Regulatory Affairs Professionals? What are the Roles of Regulatory Affairs professionals? What is an Investigational New Drug (IND) application? It is an application that is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA What is a New Drug Application? The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational new drug become part of the NDAIn simple words, “It is an application which is filed with FDA to market a new Pharmaceutical for sale in the USA” What is an Abbreviated New Drug Application (ANDA)? It is an application filed with FDA, for a U.S. generic drug approval for an existing licensed medication or approved drug.In simple words, “It is an application for the approval of Generic Drugs “ What is a Generic Drug Product? A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use. What is a DMF? A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.Important facts regarding DMFs· It is submitted to FDA to provide confidential information· Its submission is not required by law or regulations· It is neither approved nor disapproved· It is filed with FDA to support NDA, IND, ANDA another DMF, or amendments and supplements toany of these· It is provided for in the 21 CFR (Code of Federal Regulations) 314. 420· It is not required when the applicant references its own information What are the types of DMFs? Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (No longer accepted by FDA)Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or DrugProductType III: Packaging MaterialType IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their PreparationType V: FDA Accepted Reference Information (FDA discourages its use) What is a 505 (b) (2) application? 505 (b)(2) application is a type of NDA for which one or more investigations relied on by the applicant for approval were not conducted by/for the applicant and for which the applicant has not obtained a right of reference. What kind of application can be submitted as a 505(b)(2) application? What are the examples of changes to approved drug products for which 505(b)(2) applicationshould be submitted? What are the chemical classification codes for NDA? What are the differences between NDA and 505 (b)(2) application? New Drug Application (NDA) 505 (b)(2) Application All investigations relied on by the applicant for approval were conducted by/for the applicant and for which the applicant has the right of reference One or more investigations relied on by the applicant for approval were not conducted by/for the applicant and for which the applicant has not obtained a right of reference Generally, filed for newly invented pharmaceuticals. Generally, filed for new dosage form, new route of administration, new indication, etc for all already approved pharmaceuticals. Note: 505 (b)(2) application is a type of NDA. What is a Marketing Authorization Application? It is an application filed with the relevant authority in Europe (typically, the UK’s MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine. As per UK’s MHRAApplications for new active substances are described as ‘full applications’. Applications for medicines containing existing active substances are described as ‘abbreviated’ or ‘abridged applications’. What is an ASMF? An active substance master file is a submission that is made to EMA, MHRA, or any other Drug Regulatory Authority in Europe to provide a confidential intellectual property or ‘know-how’ of the manufacturer of the active substance. In simple words, “It is a submission made to European Drug regulatory agencies on the confidential information of Active Substance or Active Pharmaceutical Ingredient (API)”. What are the types of active substances for which ASMFs are submitted? What is the difference between DMF and ASMF (concerning submission)? ASMF is submitted as Applicant’s Part (Open Part) and Restricted Part (Closed Part) There isn’t any differentiation of DMFs into parts What is ICH? International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): is a project that brings together the regulatory authorities of Europe, Japan, and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. What is CTD? The Common Technical Document (CTD) is a set of specifications for the application dossier, for the registration of Medicines and is designed to be used across Europe, Japan, and the United States. Quality, Safety, and Efficacy information are assembled in a common format through CTD. The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration ofPharmaceuticals for Human Use (ICH). CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia, etc. What are the ICH guidelines to be referred to for the preparation of registration dossiers/applications of medicines (With respect to format and contents in each module)? What are the modules in CTD? What is Orange Book? It is the commonly used name for the book “Approved Drug Products with Therapeutic Equivalence Evaluations”, which is published by USFDA. It contains the list of drug products, approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food,

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Centralized Monitoring/Risk-Based Monitoring

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Centralized monitoring is a remote evaluation of the study data, carried out by a team including central monitors, and medical reviewers at a location other than the sites at which the clinical investigation is being conducted. The major difference between CRA monitor and centralized monitor is onsite monitoring and centralized monitoring respectively. Before you appear for an Interview, kindly read the below guidelines; https://cdsco.gov.in › CDSCO_WEB › Pdf-documents https://www.fda.gov › files › drugs › published Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. Careful and frequent monitoring can ensure the early discovery of pitfalls during the course of a clinical trial. Traditionally, monitoring was done through full-scale Source Data Verification( SDV) which involved traditional verification of all collected data from source documents and records. In due course of time, four algorithm-dependent approaches arbitrary SDV approach, the declining SDV approach, the three-tiered SDV approach, and mixed approaches were enforced to reduce the manual trouble and time involved in SDV. While these ways were an enhancement to the traditional SDV process, the associated trouble, time and costs were still significantly high, charging the collaborative trouble of assiduity and nonsupervisory actors to look out for indispensable approaches. The following are the major challenges of 100 SDV approach to trial monitoring So How Does RBM Work? RBM focuses on high-threat areas – scientifically as well as operationally – and leverages technology and other coffers to alleviate these pitfalls. The first step for successful RBM is threat assessment and defining the high-threat areas. Hence, it’s important to identify the KRIs( crucial threat pointers) and put in place the right triggers, cautions, and responses. After the assessment, threat mitigation and threat operation strategies come in play. ICH GCP E6 (R2) section 5 indicates risk-based monitoring i.e centralized monitoring under the sponsor’s responsilities. The sponsor should implement a system to manage quality throughout all stages of the trial process. Sponsors should focus on trial activities essential to ensuring human subject protection and the reliability of trial results. Quality management includes the design of efficient clinical trial protocols, tools, and procedures for data collection and processing, as well as the collection of information that is essential to decision making.The methods used to assure and control the quality of the trial should be proportionate to the risks inherent in the trial and the importance of the information collected. The sponsor should ensure that all aspects of the trial are operationally feasible and should avoid unnecessarycomplexity, procedures, and data collection. Protocols, case report forms, and other operational documents should be clear, concise, and consistent. The quality management system should use a risk-based approach as described below; The Transition towards Risk-based Quality Management The FDA has honored the capabilities of threat-grounded monitoring to ameliorate quality in all phases throughout the course of study trials. The most significant changes in ICH E6( R2) have been enforced to contend on guarantors and CROs to borrow a threat-grounded approach for study prosecution. The ultramodern automated RBM results grease centralized, off-point monitoring with the ideal to minimize the pitfalls associated with study trials coupled with the perpetration of GCP, SDR, and Planning criteria. The ultramodern approach would also exclude the need to suffer the repeated process, by landing the particular information of the threat assessment which needs corrective action for posterior reviews. The system captures all the information and the workflow process which can be validated by the controllers fluently along with time and date stamps. threat- grounded monitoring has the implicit to dramatically reduce the costs, time, and crimes without any adverse impact on the overall trial quality. Remote Monitoring -SCOPE When the RBM team takes over, it “monitors the data in nearly real time to uncover inconsistencies, deviations, and data errors.” It also “conducts performance assessments to unveil poor performance, potential noncompliance, and misconduct.” If any red flags are raised based on key risk indicators (KRIs), the RBM team deploys an FM to the site for a visit. Adopting this dual approach ensures the time savings and efficiency of RBM with the localized and first-hand analysis of onsite visits. The monitoring process As bandied over, the FDA has handed some detailed guidance on how to prepare a monitoring plan, but once the plan is in place, it’s the guarantor’s responsibility( or the guarantor’s delegate, like a CRO) to execute the plan. While specifics will differ extensively between studies, a threat- acquainted monitoring program will generally contain the following conditioning, which all flow through a comprehensive threat dashboard erected for your particular study Career Opportunities Any science graduate Msc, B.pharm, M.pharm, PharmD, Diploma in clinical research candidate can apply for this position. Centralised Monitoring Assistant (CMA): Fresher to 1-year experience Centralized Monitor (CM): 1-5 years of experience in Centralised monitoring or Onsite monitoring Associate Centralized Monitoring Lead (ACML): 5-8 years of experience in clinical trials Centralized Monitoring Lead (CML): 8-12 years of experience Centralized Monitoring Manager: 12-16 years of experience in clinical trials Centralized Monitoring Director: 16–20 years of experience in clinical trials Key Responsibilities of Centralised Monitor Bonus Tip Before appearing in the Interview, kindly read about all EDC platforms being used in clinical trials, i.e., eTMF, eCRF, CTMS, subject diaries, and IWRS systems. TAGS: CLINICAL RESEARCH, CLINICAL TRIAL, CLINICAL TRIALS, CLINICALRESEARCH, CLINICALTRIALS, CRO, ETMF

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Mastering the Art of Job Application Emails: 12 Templates and Tips

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In today’s competitive job market, standing out to potential employers is more crucial than ever. One of the first hurdles in the job application process is crafting an email that not only captures the attention of hiring managers but also convincingly conveys your suitability for the role. Whether you’re a recent graduate, a seasoned professional, or transitioning careers, mastering the art of the job application email is an essential skill. Below, we offer 12 customizable templates and invaluable tips to help you make a memorable first impression.

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The Journey of Clinical Trials: From Startup to Close Out

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The development of medical treatments and drugs is a meticulous and structured process, involving several phases known as clinical trials. Each phase of a clinical trial is critical and serves a specific purpose in the overall development of new medical treatments. Let’s delve into the journey of clinical trials, from the Startup Phase to the Close Out Phase, to understand how medical research evolves from a concept into a cure. Startup Phase Initiation Phase Conduct Phase Close Out Phase The process of a clinical trial is intricate and requires precision at every step. It’s a journey of discovery that lays the foundation for medical advancements and ensures the safety and efficacy of new treatments. Each phase of the trial plays a pivotal role in transforming a medical hypothesis into a treatment that can save lives and improve the quality of life for patients around the world.

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Source documentation in clinical trials

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We all have heard this saying “If it’s not documented, it didn’t happen” concerning clinical trials. But the question is for clinical trials what is to be documented and how? Today we will walk through insights about source documents in clinical research. Source means originality. Source documents are original documents, data, or records that are created during a clinical study trial. Source documents are essential documents that are required by regulatory and GCP guidelines. There are Source Documents of 2 types: Electronic Source Data which is audio, pictorial, text, graphics, reports, or other information created in digital form that is modified, maintained, archived, or retrieved by a computer system or electronic system. Requirements for Electronic Source Documents:1) Computer system (validation)2) Electronic records (audit trail)3) Electronic signatures4) Users and technical support Guidelines :21 CFR Part 11 Guidelines; Electronic Records – Electronic signatures (1997)Guidance for Industry: Part 11, Electronic Records; Electronic Signatures GuidelinesScope and Application (2003)Guidance for Industry: Computerized Systems Used in ClinicalInvestigations (2007)Electronic Source Data in Clinical Investigations – (2013) Guidance for Industry Paper Source Handwritten data are prepared on the pre-printed forms.Handwritten source documents are either handwritten or printed documents (pre-filled), with the original handwritten Investigator’s signature. The following aspects should be taken into consideration while selecting source documents: Documents which are considered as Source Documentation: Purpose of Source documentation: Source Document Verification (SDV) The main challenges during SDV are: Documentation should be able to provide an audit trail to permit investigation if and when required. Key attributes for good documentation practice described in the form of ALCOA & ALCOA+ – attributable, legible, contemporaneous, original and accurate. ALCOA+ is with few more concepts which are complete, consistent, enduring, available. Some qualities of Good documentation practices defined by USFDA and EMEA are as follows: It should be clear who has performed the action and documented the data. Attributable The information should be documented at the correct time frame when the action performed along with the flow of events. An acceptable amount of delay should be defined and justified remark. Original, or authorised true copy, the first record which is made by the designated person. The investigator should have the record of original source document. Accurate, consistent and real representation of facts. Long-lasting and durable. Easily available and accessible for review or present of data during audits/inspections. The documents should be retrievable in a reasonable time. Complete till that point in time. Demonstrate the required attributes consistently. Based on real and reliable facts. The data should be backed up by evidence. Data can be captured electronically by the following ways: References: Content : Pooja Parab

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What is an Investigator Site File (ISF)

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In the context of clinical trials, ISF stands for “Investigator Site File,” which is a collection of documents and records that are maintained by the clinical trial site or investigator. The ISF contains all essential documents that demonstrate compliance with Good Clinical Practice (GCP) guidelines, applicable regulations, and study-specific protocols. The ISF binder is a physical or electronic folder that contains all the documents that make up the Investigator Site File. The ISF binder serves as a central repository for all study-related documents, including the signed informed consent forms, ethics committee approval letters, study protocols and amendments, participant medical records, and other important trial-related documents. The ISF binder is typically maintained by the clinical trial site or investigator and must be kept up-to-date throughout the study. The binder is often audited by sponsors, regulatory authorities, and independent review boards to ensure that the trial is being conducted in compliance with applicable regulations and guidelines. The Investigator Site File (ISF) is a critical component of clinical trials. It is a comprehensive collection of documents that provide evidence of the compliance of the clinical trial site with Good Clinical Practice (GCP) guidelines, regulatory requirements, and study-specific protocols. The ISF binder is a physical or electronic folder that contains all the essential documents that make up the Investigator Site File. In this article, we will discuss the uses, examples, and electronic ISF of the ISF binder in clinical trials. Why ISF Binder in Clinical Trials? The ISF binder plays an essential role in the management of clinical trials. It serves as the central repository for all the documents that are necessary to demonstrate the compliance of the clinical trial site with GCP guidelines, regulatory requirements, and study-specific protocols. The following are the key uses of the ISF binder in clinical trials: The ISF binder contains all the documents that demonstrate compliance with GCP guidelines, regulatory requirements, and study-specific protocols. It provides the necessary evidence that the clinical trial site has followed all the procedures and requirements to ensure the safety, rights, and well-being of the study participants. The ISF binder is the primary source of documentation for regulatory authorities, sponsors, and independent review boards to verify the conduct of the clinical trial. It facilitates audits and inspections and ensures that the study site is maintaining accurate and complete records. The ISF binder contains all the documents that are necessary to verify the accuracy, completeness, and validity of the clinical trial data. It helps to ensure that the data collected during the study is of high quality and can be used for statistical analysis and reporting. Examples of Documents in ISF Binder: The ISF binder contains a range of documents that provide evidence of the compliance of the clinical trial site with GCP guidelines, regulatory requirements, and study-specific protocols. The following are some examples of documents that are typically included in the ISF binder: The study protocol is the primary document that outlines the objectives, methodology, and procedures of the clinical trial. It is a critical document that provides the framework for the conduct of the study. Any amendments made to the study protocol are also included in the ISF binder. The informed consent form is a document that explains the nature of the study, the procedures involved, and the risks and benefits of participation. It also outlines the participant’s rights and obligations during the study. The signed informed consent form of each participant is included in the ISF binder. Before a clinical trial can begin, it must receive approval from an independent ethics committee or institutional review board. The approval letter from the ethics committee is included in the ISF binder to demonstrate that the clinical trial site has obtained the necessary approvals to conduct the study. The Investigator Brochure is a document that provides information about the investigational product being tested in the clinical trial. It contains information about the pharmacology, toxicology, and clinical experience of the product. The Investigator Brochure is included in the ISF binder to provide the necessary information about the investigational product to the clinical trial site. The participant medical records contain information about the health status, medical history, and test results of the study participants. These records are necessary to monitor the safety and well-being of the participants during the study. The participant medical records are included in the ISF binder to provide a comprehensive record of the study participant’s health. Electronic ISF: In clinical trials, the Investigator Site File (ISF) is a critical component that provides evidence of the compliance of the clinical trial site with Good Clinical Practice (GCP) guidelines, regulatory requirements, and study-specific protocols. Traditionally, the ISF has been maintained in a physical binder containing all the necessary documents. However, with the advancement of technology, electronic ISFs have become increasingly popular. In this article, we will discuss what an electronic ISF is, its benefits, and examples of electronic ISFs used in clinical trials. What is an Electronic ISF? An electronic ISF is a digital system that manages all the documents required to demonstrate compliance with GCP guidelines, regulatory requirements, and study-specific protocols. Electronic ISFs typically consist of a secure, web-based platform that allows users to upload, store, and manage documents online. Benefits of Electronic ISF: Electronic ISFs offer several advantages over traditional paper-based systems, including: Electronic ISFs reduce the time and effort required to maintain and manage the documents. Since electronic ISFs are digital, users can easily upload and manage documents from any location with an internet connection. This eliminates the need to maintain physical copies of documents, which can be time-consuming and prone to errors. Electronic ISFs are accessible to all authorized users at any time, from anywhere. This means that clinical trial team members can access the documents they need quickly and easily, without having to physically locate the ISF binder. Electronic ISFs provide enhanced security features such as access control, audit trails, and encryption. This ensures that sensitive information is protected and that only authorized personnel can access the documents.

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Electronic Trial Master File

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Electronic trial master file (eTMF) is an electronic mode of collection of essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated. It is the story of how the trial was conducted and managed. Management of essential trial documentation is undoubtedly one of the most time-consuming and costly activities associated with conducting a clinical trial. A Trial Master file should present a historical look at the actions that have been taken throughout a clinical trial. A well-kept TMF can help with efficient trial management and can facilitate the reconstruction of the conduct of the trial during the audit or inspection process. Most paper-based industries and processes have matured and benefited from some kind of digital transformation. A variety of document management software has made workplace processes far more efficient. Legal, healthcare, IT, and Financial industries along with numerous other industries have all leveraged software technologies to impact the efficiency and effectiveness of their processes. The pharmaceutical and biotech industry is no different. Need for the digitization of TMF Until recently, before Information Technology (IT) became prominent in the research and medical field, managing Clinical trial regulatory documents had been paper-based. The size and complexity of a TMF were in direct proportion to the length and complexity of the trial. Paper-based processes were laborious, costly, and prone to errors. Providing a digital platform and strategy around the capture, management, and reporting of regulatory documents was necessary to enable clinical trial stakeholders to be more productive, and effective, and reduce business risk. Also, the format of a TMF, the content names, and requirements varied from sponsor to sponsor, creating a high degree of variability and inconsistency. Electronic Trial Master File (eTMF) An industry-wide momentum to streamline clinical trial processes and adopt applications to improve operational efficiency resulted in the adoption of digital processes to create and manage TMFs. A way of capturing, managing, sharing, and storing those essential documents and content from a clinical trial in a digital format is called an electronic master file or eTMF. In simple terms, it is a Trial Master File in electronic or digital format. It is a specialized content management system used to manage clinical documents across the life cycle of a clinical trial. An eTMF system automates manual paper-based Trial Master File processes. The International Conference on Harmonization (ICH) has defined a set of guidelines on Good Clinical Practice (GCP) and each TMF should adhere to the guidelines defined by ICH. Any eTMF service providing the company should stick to ICH guidelines. Though the format may be different they have to essentially focus on these key items in an e-TMF: Benefits of eTMF Leading eTMF software’s These are the Industry’s top leading eTMF software. Ennov Veeva Vault Qualsys Medidata Phlexglobal Clinevotech Arivis Veristat Florence Capterra Wingspan Future scope of eTMF Pharma and biotechnology companies are investing a lot in digitization. With gaining acceptance of eTMF in clinical trials, increased funding, and a rise in R&D programs by pharma companies, the worldwide eTMF market is expected to show exponential growth over the next decade. The high growth of electronic trial master file (eTMF) can be attributed to the growing number of clinical trials across the globe and government regulations keeping eTMF mandatory for clinical trials. eTMF will soon cease being just a repository to store and manage files. Companies are using Cloud-based models, Artificial Intelligence (AI), Machine Learning, and other high-quality data and document management systems to generate extensive reports. The future aim is to achieve real-time inspection and analysis of data, audit readiness, and on-the-fly report generation. Thank you for reading. Article By : Shahenaz Karadesai.

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Informed Consent Form – Beginner Guide

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Before we understand the informed consent process, the question arises as to why informed consent is required. Can’t a patient visit the hospital and complete the trial process? Why consent is 1st process before initiating a trial? The recorded history of clinical trials goes back to the biblical descriptions in 500 BC. The journey runs from dietary– legumes and lemons – to drugs. After the basic approach of the clinical trial was described in the 18th century, efforts were made to refine the design and statistical aspects. These were followed by changes in the regulatory and ethics milieu. History of Clinical Trials; During the above-mentioned trials from 562 BC to 1945, no consent was taken for the trials. Due to sulphonamide, thalidomide, and Nazi trials tragedies, during world war II, the Nuremberg Code was introduced considering the ethics and voluntariness of trials. The brush with thalidomide tragedy helped the U.S. pass the 1962 Kefauver-Harris amendments, which strengthened federal oversight of drug testing and included a requirement for informed consent. What is Informed Consent? Informed Consent is the process of consenting for the protection of human subjects in clinical research requires that an investigator obtain the legally effective informed consent of the subject or the subject’s legally authorized Representative I.e LAR. The main source of data for subjects considering participating in clinical trials is the Consent Form (ICF). An ICF may be a document that needs a participant’s signature upon participating in a clinical research study. The document should provide detailed information about the study the participant is participating, in and ensure that all the details are given completely, including the risks and benefits of the study. What is an informed consent Document? The informed consent document is a document of more than 15 pages and contains all information related to the proposed trial that the patient/subject needs to decide to take part in the clinical trials. An informed consent document provides sufficiently detailed information on the trial so that the patient/subject can make an informed, voluntary, and rational decision to participate. These include: The purpose of the clinical study Expected duration of trial Periods of trial e.g. 2 period, 3 period Procedures of the trial Information on their right to decline or consent to withdraw Potential risk, discomfort, or adverse effects Prospective research benefits Compensation, such as payment or rewards Whom to contact for questions i.e. Investigator contact number and IEC member contact number Lastly, as part of obtaining informed consent, a researcher must allow ample time for questions the participants might have. The answers should provide sufficient information without compromising the study. Obtaining Informed Consent All of the above-mentioned aspects must be provided to the patient/subject/participant before they are entered into the study. Informed consent must be documented by written consent in language that is reasonably understandable to participants. Most researchers use a written form that the participants sign and date and written proof is valuable in the courtroom settings, if needed. If you are a life sciences, pharma, or medical graduate, and you want to prepare for ICF; Let’s develop an informed consent for a study involving the interaction with others. Your informed consent must have: Key to good consent is matching the way the knowledge is relayed to the participant – as Canadian philosopher McLuhan once said, “The medium is the message.” Clinical research may be a complex subject and touches on difficult science. it’s easy for researchers unwittingly to pepper the ICF with scientific terms and jargon – but this must be avoided at the least cost. What information does one have to include in a consent Form? 1. What the trial is for and the way it’ll be run The participant must appreciate the trial is for research purposes, what its aims are, the character of the treatments and therefore the probability for random assignment to everyone, the trial procedure (especially any laboratory or invasive procedures), and which aspects are experimental, they need to understand how long their participation is probably going to last, roughly what percentage other subjects are involved, and therefore the circumstances under which their participation (or the trial in its entirety) could also be terminated. 2. The risks and potential benefits They must grasp the reasonably foreseeable risks or inconveniences and therefore the reasonably expected benefits (including any expenses or payment for taking part), plus any compensation or treatment available just in case something goes wrong. 3. Responsibilities and confidentiality Participants must understand their responsibilities also as those of the staff running the trial. They need to appreciate that their identity will remain confidential except that the monitors, the auditors, the IRB/IEC, and therefore the regulatory authorities are going to be granted direct access to their original medical records for verification of clinical test procedures. The participants are going to be informed promptly if further information involves light which will affect them. They need to be told who to contact for further information regarding the trial and therefore the rights of trial subjects, as well as within the event of a trial-related injury. 4. The voluntary nature or participation Participants must understand that their participation is voluntary. They have the right to refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which they’re otherwise entitled. 5. Additional information The US FDA requires certain additional pieces of knowledge depending upon the trial. These include a handout that the particular treatment or procedure may involve currently unforeseeable risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), additional costs to the subject which can result from participation within the research, and thus the results of a subject’s decision to withdraw from the research. The FDA also requires that the next statement be provided to each clinical trial subject: “A description of this clinical trial is getting to be available on [http://www.clinicaltrials.gov/], as required by U.S. Law. This website won’t include information that can identify you. At most, the

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