Regulatory compliance in clinical research is paramount to ensure patient safety, data integrity, and ethical standards. Key events like the Nuremberg Code, Declaration of Helsinki, and thalidomide tragedy led to increasingly stringent regulations. Major regulatory agencies oversee clinical trials globally, including the FDA, EMA, and ICH. Regulations require ethics review, informed consent, safety monitoring, data handling procedures, and transparency. Good Clinical Practice guidelines provide an international standard for the ethical and scientific conduct of clinical trials. Maintaining regulatory compliance is crucial for credible research and continued innovation.
The Changing Landscape of Clinical Research Regulations: Updates and Implicat...ClinosolIndia
The landscape of clinical research regulations is constantly evolving to adapt to the changing needs of the research community, advancements in scientific understanding, and the protection of research participants. Here are some key updates and implications that have shaped the current state of clinical research regulations
ICH GCP guidelines for mpharmacy 2nd sem 204T subject.
topic include the brief description regarding ICH GCP
THE GOOD CLINICAL PRACTICES AND
THE INTERNATIONAL CONFERENCE OF HORMONIZATION.
THAT INCLUDE the regulation of all pharmaceutical industries.
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
The Changing Landscape of Clinical Research Regulations: Updates and Implicat...ClinosolIndia
The landscape of clinical research regulations is constantly evolving to adapt to the changing needs of the research community, advancements in scientific understanding, and the protection of research participants. Here are some key updates and implications that have shaped the current state of clinical research regulations
ICH GCP guidelines for mpharmacy 2nd sem 204T subject.
topic include the brief description regarding ICH GCP
THE GOOD CLINICAL PRACTICES AND
THE INTERNATIONAL CONFERENCE OF HORMONIZATION.
THAT INCLUDE the regulation of all pharmaceutical industries.
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
What is The Clinical Trial Approval Process In India.pdfPranshuCorpseed
Clinical trials are critical in the development of novel medications and cures, advancing medical science and patient care. The clinical trial ecosystem in India has grown dramatically, making it an appealing destination for pharmaceutical research. This article explores the regulatory framework, ethical concerns, phases of clinical trials, application processes, review, post-approval requirements, obstacles, case studies, and future prospects of clinical trial approval in India.
intertnational council for harmonization The International Council for Harmonisation of Technical Requirements for 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 Details of the ICH guidelines for pharmaceutical quality from Q1 to Q12 including stability analysis, evaluation of impurities and quality risk management. ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical guidelines for industries.
ICH GUIDELINES, ICH, INTERNATIONAL CONFERENCE ON HARMONIZATION, B PHARMA 6TH SEM, PHARMACEUTICAL QUALITY ASSURANCE
ICH and ICH guidelines
Need
Origin of ICH
Evolution of ICH
ICH members
Steps of ICH
STEP 1: Building Scientific Consensus
STEP 2: Agreeing on Draft Text
STEP 3: Consulting Regional Regulatory Agencies
STEP 4: Adopting Harmonized Guidelines
STEP 5: Implementing Guidelines in ICH Regions
Categories of ICH guidelines
1.5 international conference on harmonizationShital Patil
ICH is a joint initiative involving both regulators and research-based industry representatives of the EU, Japan and the US in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality and efficacy of medicines.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
The International Classification of Diseases (ICD) is a globally recognized system for classifying and coding diseases, health conditions, and related factors. It is maintained and updated by the World Health Organization (WHO) and serves several critical functions in healthcare and epidemiology. To describe the ICD comprehensively within 3000 characters, we'll cover its history, purpose, structure, and significance.
**History:**
The roots of the ICD can be traced back to the mid-19th century when various countries began documenting statistics on causes of death. The need for a standardized classification system became evident as different nations used their own systems, hindering international comparisons. The ICD was officially established in its modern form in 1948, with subsequent revisions and updates.
**Purpose:**
The primary purposes of the ICD are as follows:
1. **Disease Classification:** The ICD provides a systematic way to categorize diseases and health conditions. Each condition is assigned a unique code, which simplifies data collection and reporting.
2. **Clinical Diagnosis:** Healthcare professionals use the ICD to document and communicate diagnoses. This aids in patient care, medical billing, and insurance claims processing.
3. **Epidemiology:** The ICD is crucial for monitoring and analyzing disease patterns on a global scale. It helps identify emerging health threats, allocate resources, and develop public health policies.
4. **Health Statistics:** Governments and health organizations use the ICD to compile health statistics, such as causes of death and disease prevalence. This information guides healthcare planning and resource allocation.
**Structure:**
The ICD is organized into chapters, sections, and codes. The current version, ICD-10, is divided into 22 chapters, covering a wide range of health-related topics. Here's an overview of some key chapters:
- **Chapter I:** Certain infectious and parasitic diseases
- **Chapter II:** Neoplasms (cancers)
- **Chapter III:** Diseases of the blood and blood-forming organs
- **Chapter IV:** Endocrine, nutritional, and metabolic diseases
- **Chapter V:** Mental and behavioral disorders
- **Chapter VI:** Diseases of the nervous system
- **Chapter VII:** Diseases of the eye and adnexa
- **Chapter VIII:** Diseases of the ear and mastoid process
- **Chapter IX:** Diseases of the circulatory system
- **Chapter X:** Diseases of the respiratory system
- **Chapter XI:** Diseases of the digestive system
- **Chapter XII:** Diseases of the skin and subcutaneous tissue
- **Chapter XIII:** Diseases of the musculoskeletal system and connective tissue
- **Chapter XIV:** Diseases of the genitourinary system
- **Chapter XV:** Pregnancy, childbirth, and the puerperium
- **Chapter XVI:** Certain conditions originating in the perinatal period
- **Chapter XVII:** Congenital malformations, deformations, and chromosomal abnormalities
- **Chapter XVIII:** Symptoms, signs, and abnormal clinical and labor
‘Six Sigma Technique’ A Journey Through its Implementationijtsrd
The manufacturing industries all over the world are facing tough challenges for growth, development and sustainability in today’s competitive environment. They have to achieve apex position by adapting with the global competitive environment by delivering goods and services at low cost, prime quality and better price to increase wealth and consumer satisfaction. Cost Management ensures profit, growth and sustainability of the business with implementation of Continuous Improvement Technique like Six Sigma. This leads to optimize Business performance. The method drives for customer satisfaction, low variation, reduction in waste and cycle time resulting into a competitive advantage over other industries which did not implement it. The main objective of this paper ‘Six Sigma Technique A Journey Through Its Implementation’ is to conceptualize the effectiveness of Six Sigma Technique through the journey of its implementation. Aditi Sunilkumar Ghosalkar "‘Six Sigma Technique’: A Journey Through its Implementation" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64546.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64546/‘six-sigma-technique’-a-journey-through-its-implementation/aditi-sunilkumar-ghosalkar
Edge Computing in Space Enhancing Data Processing and Communication for Space...ijtsrd
Edge computing, a paradigm that involves processing data closer to its source, has gained significant attention for its potential to revolutionize data processing and communication in space missions. With the increasing complexity and data volume generated by modern space missions, traditional centralized computing approaches face challenges related to latency, bandwidth, and security. Edge computing in space, involving on board processing and analysis of data, offers promising solutions to these challenges. This paper explores the concept of edge computing in space, its benefits, applications, and future prospects in enhancing space missions. Manish Verma "Edge Computing in Space: Enhancing Data Processing and Communication for Space Missions" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64541.pdf Paper Url: https://www.ijtsrd.com/computer-science/artificial-intelligence/64541/edge-computing-in-space-enhancing-data-processing-and-communication-for-space-missions/manish-verma
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What is The Clinical Trial Approval Process In India.pdfPranshuCorpseed
Clinical trials are critical in the development of novel medications and cures, advancing medical science and patient care. The clinical trial ecosystem in India has grown dramatically, making it an appealing destination for pharmaceutical research. This article explores the regulatory framework, ethical concerns, phases of clinical trials, application processes, review, post-approval requirements, obstacles, case studies, and future prospects of clinical trial approval in India.
intertnational council for harmonization The International Council for Harmonisation of Technical Requirements for 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 Details of the ICH guidelines for pharmaceutical quality from Q1 to Q12 including stability analysis, evaluation of impurities and quality risk management. ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical guidelines for industries.
ICH GUIDELINES, ICH, INTERNATIONAL CONFERENCE ON HARMONIZATION, B PHARMA 6TH SEM, PHARMACEUTICAL QUALITY ASSURANCE
ICH and ICH guidelines
Need
Origin of ICH
Evolution of ICH
ICH members
Steps of ICH
STEP 1: Building Scientific Consensus
STEP 2: Agreeing on Draft Text
STEP 3: Consulting Regional Regulatory Agencies
STEP 4: Adopting Harmonized Guidelines
STEP 5: Implementing Guidelines in ICH Regions
Categories of ICH guidelines
1.5 international conference on harmonizationShital Patil
ICH is a joint initiative involving both regulators and research-based industry representatives of the EU, Japan and the US in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality and efficacy of medicines.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
The International Classification of Diseases (ICD) is a globally recognized system for classifying and coding diseases, health conditions, and related factors. It is maintained and updated by the World Health Organization (WHO) and serves several critical functions in healthcare and epidemiology. To describe the ICD comprehensively within 3000 characters, we'll cover its history, purpose, structure, and significance.
**History:**
The roots of the ICD can be traced back to the mid-19th century when various countries began documenting statistics on causes of death. The need for a standardized classification system became evident as different nations used their own systems, hindering international comparisons. The ICD was officially established in its modern form in 1948, with subsequent revisions and updates.
**Purpose:**
The primary purposes of the ICD are as follows:
1. **Disease Classification:** The ICD provides a systematic way to categorize diseases and health conditions. Each condition is assigned a unique code, which simplifies data collection and reporting.
2. **Clinical Diagnosis:** Healthcare professionals use the ICD to document and communicate diagnoses. This aids in patient care, medical billing, and insurance claims processing.
3. **Epidemiology:** The ICD is crucial for monitoring and analyzing disease patterns on a global scale. It helps identify emerging health threats, allocate resources, and develop public health policies.
4. **Health Statistics:** Governments and health organizations use the ICD to compile health statistics, such as causes of death and disease prevalence. This information guides healthcare planning and resource allocation.
**Structure:**
The ICD is organized into chapters, sections, and codes. The current version, ICD-10, is divided into 22 chapters, covering a wide range of health-related topics. Here's an overview of some key chapters:
- **Chapter I:** Certain infectious and parasitic diseases
- **Chapter II:** Neoplasms (cancers)
- **Chapter III:** Diseases of the blood and blood-forming organs
- **Chapter IV:** Endocrine, nutritional, and metabolic diseases
- **Chapter V:** Mental and behavioral disorders
- **Chapter VI:** Diseases of the nervous system
- **Chapter VII:** Diseases of the eye and adnexa
- **Chapter VIII:** Diseases of the ear and mastoid process
- **Chapter IX:** Diseases of the circulatory system
- **Chapter X:** Diseases of the respiratory system
- **Chapter XI:** Diseases of the digestive system
- **Chapter XII:** Diseases of the skin and subcutaneous tissue
- **Chapter XIII:** Diseases of the musculoskeletal system and connective tissue
- **Chapter XIV:** Diseases of the genitourinary system
- **Chapter XV:** Pregnancy, childbirth, and the puerperium
- **Chapter XVI:** Certain conditions originating in the perinatal period
- **Chapter XVII:** Congenital malformations, deformations, and chromosomal abnormalities
- **Chapter XVIII:** Symptoms, signs, and abnormal clinical and labor
‘Six Sigma Technique’ A Journey Through its Implementationijtsrd
The manufacturing industries all over the world are facing tough challenges for growth, development and sustainability in today’s competitive environment. They have to achieve apex position by adapting with the global competitive environment by delivering goods and services at low cost, prime quality and better price to increase wealth and consumer satisfaction. Cost Management ensures profit, growth and sustainability of the business with implementation of Continuous Improvement Technique like Six Sigma. This leads to optimize Business performance. The method drives for customer satisfaction, low variation, reduction in waste and cycle time resulting into a competitive advantage over other industries which did not implement it. The main objective of this paper ‘Six Sigma Technique A Journey Through Its Implementation’ is to conceptualize the effectiveness of Six Sigma Technique through the journey of its implementation. Aditi Sunilkumar Ghosalkar "‘Six Sigma Technique’: A Journey Through its Implementation" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64546.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64546/‘six-sigma-technique’-a-journey-through-its-implementation/aditi-sunilkumar-ghosalkar
Edge Computing in Space Enhancing Data Processing and Communication for Space...ijtsrd
Edge computing, a paradigm that involves processing data closer to its source, has gained significant attention for its potential to revolutionize data processing and communication in space missions. With the increasing complexity and data volume generated by modern space missions, traditional centralized computing approaches face challenges related to latency, bandwidth, and security. Edge computing in space, involving on board processing and analysis of data, offers promising solutions to these challenges. This paper explores the concept of edge computing in space, its benefits, applications, and future prospects in enhancing space missions. Manish Verma "Edge Computing in Space: Enhancing Data Processing and Communication for Space Missions" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64541.pdf Paper Url: https://www.ijtsrd.com/computer-science/artificial-intelligence/64541/edge-computing-in-space-enhancing-data-processing-and-communication-for-space-missions/manish-verma
Dynamics of Communal Politics in 21st Century India Challenges and Prospectsijtsrd
Communal politics in India has evolved through centuries, weaving a complex tapestry shaped by historical legacies, colonial influences, and contemporary socio political transformations. This research comprehensively examines the dynamics of communal politics in 21st century India, emphasizing its historical roots, socio political dynamics, economic implications, challenges, and prospects for mitigation. The historical perspective unravels the intricate interplay of religious identities and power dynamics from ancient civilizations to the impact of colonial rule, providing insights into the evolution of communalism. The socio political dynamics section delves into the contemporary manifestations, exploring the roles of identity politics, socio economic disparities, and globalization. The economic implications section highlights how communal politics intersects with economic issues, perpetuating disparities and influencing resource allocation. Challenges posed by communal politics are scrutinized, revealing multifaceted issues ranging from social fragmentation to threats against democratic values. The prospects for mitigation present a multifaceted approach, incorporating policy interventions, community engagement, and educational initiatives. The paper conducts a comparative analysis with international examples, identifying common patterns such as identity politics and economic disparities. It also examines unique challenges, emphasizing Indias diverse religious landscape, historical legacy, and secular framework. Lessons for effective strategies are drawn from international experiences, offering insights into inclusive policies, interfaith dialogue, media regulation, and global cooperation. By scrutinizing historical epochs, contemporary dynamics, economic implications, and international comparisons, this research provides a comprehensive understanding of communal politics in India. The proposed strategies for mitigation underscore the importance of a holistic approach to foster social harmony, inclusivity, and democratic values. Rose Hossain "Dynamics of Communal Politics in 21st Century India: Challenges and Prospects" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64528.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/history/64528/dynamics-of-communal-politics-in-21st-century-india-challenges-and-prospects/rose-hossain
Assess Perspective and Knowledge of Healthcare Providers Towards Elehealth in...ijtsrd
Background and Objective Telehealth has become a well known tool for the delivery of health care in Saudi Arabia, and the perspective and knowledge of healthcare providers are influential in the implementation, adoption and advancement of the method. This systematic review was conducted to examine the current literature base regarding telehealth and the related healthcare professional perspective and knowledge in the Kingdom of Saudi Arabia. Materials and Methods This systematic review was conducted by searching 7 databases including, MEDLINE, CINHAL, Web of Science, Scopus, PubMed, PsycINFO, and ProQuest Central. Studies on healthcare practitioners telehealth knowledge and perspectives published in English in Saudi Arabia from 2000 to 2023 were included. Boland directed this comprehensive review. The researchers examined each connected study using the AXIS tool, which evaluates cross sectional systematic reviews. Narrative synthesis was used to summarise and convey the data. Results Out of 1840 search results, 10 studies were included. Positive outlook and limited knowledge among providers were seen across trials. Healthcare professionals like telehealth for its ability to improve quality, access, and delivery, save time and money, and be successful. Age, gender, occupation, and work experience also affect health workers knowledge. In Saudi Arabia, healthcare professionals face inadequate expert assistance, patient privacy, internet connection concerns, lack of training courses, lack of telehealth understanding, and high costs while performing telemedicine. Conclusions Healthcare practitioners telehealth perceptions and knowledge were examined in this systematic study. Its collection of concerned experts different personal attitudes and expertise would help enhance telehealths implementation in Saudi Arabia, develop its healthcare delivery alternative, and eliminate frequent problems. Badriah Mousa I Mulayhi | Dr. Jomin George | Judy Jenkins "Assess Perspective and Knowledge of Healthcare Providers Towards Elehealth in Saudi Arabia: A Systematic Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64535.pdf Paper Url: https://www.ijtsrd.com/medicine/other/64535/assess-perspective-and-knowledge-of-healthcare-providers-towards-elehealth-in-saudi-arabia-a-systematic-review/badriah-mousa-i-mulayhi
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The impact of digital media on the distribution of power and the weakening of traditional gatekeepers has gained considerable attention in recent years. The adoption of digital technologies and the internet has resulted in declining influence and power for traditional gatekeepers such as publishing houses and news organizations. Simultaneously, digital media has facilitated the emergence of new voices and players in the media industry. Digital medias impact on power decentralization and gatekeeper erosion is visible in several ways. One significant aspect is the democratization of information, which enables anyone with an internet connection to publish and share content globally, leading to citizen journalism and bypassing traditional gatekeepers. Another aspect is the disruption of conventional media industry business models, as traditional organizations struggle to adjust to the decrease in advertising revenue and the rise of digital platforms. Alternative business models, such as subscription models and crowdfunding, have become more prevalent, leading to the emergence of new players. Overall, the impact of digital media on the distribution of power and the weakening of traditional gatekeepers has brought about significant changes in the media landscape and the way information is shared. Further research is required to fully comprehend the implications of these changes and their impact on society. Dr. Kusum Lata "The Impact of Digital Media on the Decentralization of Power and the Erosion of Traditional Gatekeepers" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64544.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/political-science/64544/the-impact-of-digital-media-on-the-decentralization-of-power-and-the-erosion-of-traditional-gatekeepers/dr-kusum-lata
Online Voices, Offline Impact Ambedkars Ideals and Socio Political Inclusion ...ijtsrd
This research investigates the nexus between online discussions on Dr. B.R. Ambedkars ideals and their impact on social inclusion among college students in Gurugram, Haryana. Surveying 240 students from 12 government colleges, findings indicate that 65 actively engage in online discussions, with 80 demonstrating moderate to high awareness of Ambedkars ideals. Statistically significant correlations reveal that higher online engagement correlates with increased awareness p 0.05 and perceived social inclusion. Variations across colleges and a notable effect of college type on perceived social inclusion highlight the influence of contextual factors. Furthermore, the intersectional analysis underscores nuanced differences based on gender, caste, and socio economic status. Dr. Kusum Lata "Online Voices, Offline Impact: Ambedkar's Ideals and Socio-Political Inclusion - A Study of Gurugram District" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64543.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/political-science/64543/online-voices-offline-impact-ambedkars-ideals-and-sociopolitical-inclusion--a-study-of-gurugram-district/dr-kusum-lata
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This study primarily focuses on the design of a high side buck converter using an Arduino microcontroller. The converter is specifically intended for use in DC DC applications, particularly in standalone solar PV systems where the PV output voltage exceeds the load or battery voltage. To evaluate the performance of the converter, simulation experiments are conducted using Proteus Software. These simulations provide insights into the input and output voltages, currents, powers, and efficiency under different state of charge SoC conditions of a 12V,70Ah rechargeable lead acid battery. Additionally, the hardware design of the converter is implemented, and practical data is collected through operation, monitoring, and recording. By comparing the simulation results with the practical results, the efficiency and performance of the designed converter are assessed. The findings indicate that while the buck converter is suitable for practical use in standalone PV systems, its efficiency is compromised due to a lower output current. Chan Myae Aung | Dr. Ei Mon "Design Simulation and Hardware Construction of an Arduino-Microcontroller Based DC-DC High-Side Buck Converter for Standalone PV System" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64518.pdf Paper Url: https://www.ijtsrd.com/engineering/mechanical-engineering/64518/design-simulation-and-hardware-construction-of-an-arduinomicrocontroller-based-dcdc-highside-buck-converter-for-standalone-pv-system/chan-myae-aung
Sustainable Energy by Paul A. Adekunte | Matthew N. O. Sadiku | Janet O. Sadikuijtsrd
Energy becomes sustainable if it meets the needs of the present without compromising the ability of future generations to meet their own needs. Some of the definitions of sustainable energy include the considerations of environmental aspects such as greenhouse gas emissions, social, and economic aspects such as energy poverty. Generally far more sustainable than fossil fuel are renewable energy sources such as wind, hydroelectric power, solar, and geothermal energy sources. Worthy of note is that some renewable energy projects, like the clearing of forests to produce biofuels, can cause severe environmental damage. The sustainability of nuclear power which is a low carbon source is highly debated because of concerns about radioactive waste, nuclear proliferation, and accidents. The switching from coal to natural gas has environmental benefits, including a lower climate impact, but could lead to delay in switching to more sustainable options. “Carbon capture and storage” can be built into power plants to remove the carbon dioxide CO2 emissions, but this technology is expensive and has rarely been implemented. Leading non renewable energy sources around the world is fossil fuels, coal, petroleum, and natural gas. Nuclear energy is usually considered another non renewable energy source, although nuclear energy itself is a renewable energy source, but the material used in nuclear power plants is not. The paper addresses the issue of sustainable energy, its attendant benefits to the future generation, and humanity in general. Paul A. Adekunte | Matthew N. O. Sadiku | Janet O. Sadiku "Sustainable Energy" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64534.pdf Paper Url: https://www.ijtsrd.com/engineering/electrical-engineering/64534/sustainable-energy/paul-a-adekunte
Concepts for Sudan Survey Act Implementations Executive Regulations and Stand...ijtsrd
This paper aims to outline the executive regulations, survey standards, and specifications required for the implementation of the Sudan Survey Act, and for regulating and organizing all surveying work activities in Sudan. The act has been discussed for more than 5 years. The Land Survey Act was initiated by the Sudan Survey Authority and all official legislations were headed by the Sudan Ministry of Justice till it was issued in 2022. The paper presents conceptual guidelines to be used for the Survey Act implementation and to regulate the survey work practice, standardizing the field surveys, processing, quality control, procedures, and the processes related to survey work carried out by the stakeholders and relevant authorities in Sudan. The conceptual guidelines are meant to improve the quality and harmonization of geospatial data and to aid decision making processes as well as geospatial information systems. The established comprehensive executive regulations will govern and regulate the implementation of the Sudan Survey Geomatics Act in all surveying and mapping practices undertaken by the Sudan Survey Authority SSA and state local survey departments for public or private sector organizations. The targeted standards and specifications include the reference frame, projection, coordinate systems, and the guidelines and specifications that must be followed in the field of survey work, processes, and mapping products. In the last few decades, there has been a growing awareness of the importance of geomatics activities and measurements on the Earths surface in space and time, together with observing and mapping the changes. In such cases, data must be captured promptly, standardized, and obtained with more accuracy and specified in much detail. The paper will also highlight the current situation in Sudan, the degree to which survey standards are used, the problems encountered, and the errors that arise from not using the standards and survey specifications. Kamal A. A. Sami "Concepts for Sudan Survey Act Implementations - Executive Regulations and Standards" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63484.pdf Paper Url: https://www.ijtsrd.com/engineering/civil-engineering/63484/concepts-for-sudan-survey-act-implementations--executive-regulations-and-standards/kamal-a-a-sami
Towards the Implementation of the Sudan Interpolated Geoid Model Khartoum Sta...ijtsrd
The discussions between ellipsoid and geoid have invoked many researchers during the recent decades, especially during the GNSS technology era, which had witnessed a great deal of development but still geoid undulation requires more investigations. To figure out a solution for Sudans local geoid, this research has tried to intake the possibility of determining the geoid model by following two approaches, gravimetric and geometrical geoid model determination, by making use of GNSS leveling benchmarks at Khartoum state. The Benchmarks are well distributed in the study area, in which, the horizontal coordinates and the height above the ellipsoid have been observed by GNSS while orthometric heights were carried out using precise leveling. The Global Geopotential Model GGM represented in EGM2008 has been exploited to figure out the geoid undulation at the benchmarks in the study area. This is followed by a fitting process, that has been done to suit the geoid undulation data which has been computed using GNSS leveling data and geoid undulation inspired by the EGM2008. Two geoid surfaces were created after the fitting process to ensure that they are identical and both of them could be counted for getting the same geoid undulation with an acceptable accuracy. In this respect, statistical operation played an important role in ensuring the consistency and integrity of the model by applying cross validation techniques splitting the data into training and testing datasets for building the geoid model and testing its eligibility. The geometrical solution for geoid undulation computation has been utilized by applying straightforward equations that facilitate the calculation of the geoid undulation directly through applying statistical techniques for the GNSS leveling data of the study area to get the common equation parameters values that could be utilized to calculate geoid undulation of any position in the study area within the claimed accuracy. Both systems were checked and proved eligible to be used within the study area with acceptable accuracy which may contribute to solving the geoid undulation problem in the Khartoum area, and be further generalized to determine the geoid model over the entire country, and this could be considered in the future, for regional and continental geoid model. Ahmed M. A. Mohammed. | Kamal A. A. Sami "Towards the Implementation of the Sudan Interpolated Geoid Model (Khartoum State Case Study)" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63483.pdf Paper Url: https://www.ijtsrd.com/engineering/civil-engineering/63483/towards-the-implementation-of-the-sudan-interpolated-geoid-model-khartoum-state-case-study/ahmed-m-a-mohammed
Activating Geospatial Information for Sudans Sustainable Investment Mapijtsrd
Sudan is witnessing an acceleration in the processes of development and transformation in the performance of government institutions to raise the productivity and investment efficiency of the government sector. The development plans and investment opportunities have focused on achieving national goals in various sectors. This paper aims to illuminate the path to the future and provide geospatial data and information to develop the investment climate and environment for all sized businesses, and to bridge the development gap between the Sudan states. The Sudan Survey Authority SSA is the main advisor to the Sudan Government in conducting surveying, mappings, designing, and developing systems related to geospatial data and information. In recent years, SSA made a strategic partnership with the Ministry of Investment to activate Geospatial Information for Sudans Sustainable Investment and in particular, for the preparation and implementation of the Sudan investment map, based on the directives and objectives of the Ministry of Investment MI in Sudan. This paper comes within the framework of activating the efforts of the Ministry of Investment to develop technical investment services by applying techniques adopted by the Ministry and its strategic partners for advancing investment processes in the country. Kamal A. A. Sami "Activating Geospatial Information for Sudan's Sustainable Investment Map" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63482.pdf Paper Url: https://www.ijtsrd.com/engineering/information-technology/63482/activating-geospatial-information-for-sudans-sustainable-investment-map/kamal-a-a-sami
Educational Unity Embracing Diversity for a Stronger Societyijtsrd
In a rapidly changing global landscape, the importance of education as a unifying force cannot be overstated. This paper explores the crucial role of educational unity in fostering a stronger and more inclusive society through the embrace of diversity. By examining the benefits of diverse learning environments, the paper aims to highlight the positive impact on societal strength. The discussion encompasses various dimensions, from curriculum design to classroom dynamics, and emphasizes the need for educational institutions to become catalysts for unity in diversity. It highlights the need for a paradigm shift in educational policies, curricula, and pedagogical approaches to ensure that they are reflective of the diverse fabric of society. This paper also addresses the challenges associated with implementing inclusive educational practices and offers practical strategies for overcoming barriers. It advocates for collaborative efforts between educational institutions, policymakers, and communities to create a supportive ecosystem that promotes diversity and unity. Mr. Amit Adhikari | Madhumita Teli | Gopal Adhikari "Educational Unity: Embracing Diversity for a Stronger Society" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64525.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/education/64525/educational-unity-embracing-diversity-for-a-stronger-society/mr-amit-adhikari
Integration of Indian Indigenous Knowledge System in Management Prospects and...ijtsrd
The diversity of indigenous knowledge systems in India is vast and can vary significantly between different communities and regions. Preserving and respecting these knowledge systems is crucial for maintaining cultural heritage, promoting sustainable practices, and fostering cross cultural understanding. In this paper, an overview of the prospects and challenges associated with incorporating Indian indigenous knowledge into management is explored. It is found that IIKS helps in management in many areas like sustainable development, tourism, food security, natural resource management, cultural preservation and innovation, etc. However, IIKS integration with management faces some challenges in the form of a lack of documentation, cultural sensitivity, language barriers legal framework, etc. Savita Lathwal "Integration of Indian Indigenous Knowledge System in Management: Prospects and Challenges" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63500.pdf Paper Url: https://www.ijtsrd.com/management/accounting-and-finance/63500/integration-of-indian-indigenous-knowledge-system-in-management-prospects-and-challenges/savita-lathwal
DeepMask Transforming Face Mask Identification for Better Pandemic Control in...ijtsrd
The COVID 19 pandemic has highlighted the crucial need of preventive measures, with widespread use of face masks being a key method for slowing the viruss spread. This research investigates face mask identification using deep learning as a technological solution to be reducing the risk of coronavirus transmission. The proposed method uses state of the art convolutional neural networks CNNs and transfer learning to automatically recognize persons who are not wearing masks in a variety of circumstances. We discuss how this strategy improves public health and safety by providing an efficient manner of enforcing mask wearing standards. The report also discusses the obstacles, ethical concerns, and prospective applications of face mask detection systems in the ongoing fight against the pandemic. Dilip Kumar Sharma | Aaditya Yadav "DeepMask: Transforming Face Mask Identification for Better Pandemic Control in the COVID-19 Era" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64522.pdf Paper Url: https://www.ijtsrd.com/engineering/electronics-and-communication-engineering/64522/deepmask-transforming-face-mask-identification-for-better-pandemic-control-in-the-covid19-era/dilip-kumar-sharma
Streamlining Data Collection eCRF Design and Machine Learningijtsrd
Efficient and accurate data collection is paramount in clinical trials, and the design of Electronic Case Report Forms eCRFs plays a pivotal role in streamlining this process. This paper explores the integration of machine learning techniques in the design and implementation of eCRFs to enhance data collection efficiency. We delve into the synergies between eCRF design principles and machine learning algorithms, aiming to optimize data quality, reduce errors, and expedite the overall data collection process. The application of machine learning in eCRF design brings forth innovative approaches to data validation, anomaly detection, and real time adaptability. This paper discusses the benefits, challenges, and future prospects of leveraging machine learning in eCRF design for streamlined and advanced data collection in clinical trials. Dhanalakshmi D | Vijaya Lakshmi Kannareddy "Streamlining Data Collection: eCRF Design and Machine Learning" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63515.pdf Paper Url: https://www.ijtsrd.com/biological-science/biotechnology/63515/streamlining-data-collection-ecrf-design-and-machine-learning/dhanalakshmi-d
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
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Code established the first set of ethical principles for
human experimentation. It emphasized the
importance of voluntary informed consent,
minimizing risks, and the need for scientific
justification.
Declaration of Helsinki (1964): The World Medical
Association introduced the Declaration of Helsinki,
which outlined ethical principles for medical research
involving human participants. It emphasized the role
of independent ethics committees and the necessity of
informed consent. The Declaration has undergone
several revisions to adapt to changing research
practices and ethical considerations.
Thalidomide Tragedy (1960s): The Thalidomide
disaster, where a medication caused severe birth
defects, led to increased recognition of the need for
rigorous testing and regulatory oversight before drugs
are approved for public use. This event prompted
regulatory agencies to establish more stringent safety
evaluation procedures.
Kefauver-Harris Amendments (1962): In the United
States, the Kefauver-Harris Amendments were
enacted after the thalidomide tragedy. These
amendments required drug manufacturers to prove the
effectiveness and safety of new drugs before they
could be marketed. The amendments also established
the requirement for informed consent and reporting
adverse events.
Creation of the FDA (1938) and EMA (1995): The
United States established the Food and Drug
Administration (FDA) in 1938 to regulate food,
drugs, and cosmetics. The European Medicines
Agency (EMA) was established in 1995 to oversee
the evaluation and approval of medicinal products in
the European Union.
ICH Guidelines (1990s): The International
Conference on Harmonisation (ICH) brought together
regulatory authorities and the pharmaceutical industry
to develop guidelines that harmonize regulatory
requirements across different regions. The ICH
guidelines cover various aspects of drug
development, including safety, efficacy, and quality.
Good Clinical Practice (GCP) Guidelines (1996): The
International Council for Harmonisation (ICH)
introduced the Guideline for Good Clinical Practice
(GCP), outlining ethical and scientific standards for
designing, conducting, and reporting clinical trials.
GCP emphasizes participant protection, data integrity,
and regulatory compliance.
Strengthening Oversight (2000s): Regulatory bodies
worldwide continued to enhance oversight and
enforcement of clinical trials. The introduction of
electronic data capture (EDC) systems and increased
emphasis on data transparency contributed to
improving data quality and integrity.
ClinicalTrials.gov and EudraCT (2000s): The launch
of ClinicalTrials.gov in the U.S. and the European
Union Clinical Trials Register (EudraCT) in Europe
provided platforms for registering and reporting
clinical trials, promoting transparency and reducing
publication bias.
Emergence of Risk-Based Monitoring (RBM)
(2010s): Regulatory agencies and industry shifted
towards risk-based monitoring approaches, focusing
resources on critical data and processes to improve
participant safety and data quality while reducing
administrative burdens.
Key Regulatory Bodies and Their Roles
Several key regulatory bodies play pivotal roles in
overseeing and shaping the regulatory landscape of
clinical research to ensure ethical conduct, patient
safety, and data integrity. Here are some of the major
regulatory agencies and their roles:
Food and Drug Administration (FDA):
Location: United States
Role: The FDA is responsible for regulating food,
drugs, biologics, medical devices, and cosmetics in
the United States. It reviews and approves new drugs
and medical products, including clinical trial
protocols, to ensure their safety and effectiveness.
European Medicines Agency (EMA):
Location: European Union (EU)
Role: The EMA evaluates and supervises medicinal
products within the European Union. It assesses the
safety, efficacy, and quality of medicines, including
overseeing clinical trial applications and marketing
authorizations.
International Conference on Harmonisation (ICH):
Location: Global (Multiregional)
Role: ICH brings together regulatory authorities and
the pharmaceutical industry to develop harmonized
guidelines for drug development, including clinical
trials. These guidelines aim to streamline regulatory
requirements across regions and ensure consistent
standards.
World Health Organization (WHO):
Location: Global
Role: WHO provides global leadership in public
health, including guidance on ethical standards for
clinical research. It promotes the development of
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international ethical guidelines and monitors
adherence to these principles.
Health Products Regulatory Authority (HPRA):
Location: Ireland
Role: HPRA oversees the regulation of medicines,
medical devices, and other healthcare products in
Ireland. It assesses clinical trial applications, monitors
trials' conduct, and ensures compliance with
regulations.
Pharmaceuticals and Medical Devices Agency
(PMDA):
Location: Japan
Role: PMDA evaluates and reviews new drugs,
medical devices, and regenerative medicine products
in Japan. It ensures that clinical trials follow ethical
guidelines and regulatory requirements.
Medicines and Healthcare products Regulatory
Agency (MHRA):
Location: United Kingdom
Role: MHRA regulates medicines, medical devices,
and blood components in the UK. It assesses clinical
trial applications and monitors trial conduct to ensure
compliance with ethical and regulatory standards.
Health Canada:
Location: Canada
Role: Health Canada regulates the safety, efficacy,
and quality of health products in Canada. It reviews
clinical trial applications and ensures that research
adheres to ethical principles and regulatory
requirements.
China National Medical Products Administration
(NMPA):
Location: China
Role: NMPA oversees the regulation of
pharmaceuticals and medical devices in China. It
reviews and approves clinical trial applications,
ensuring that trials follow ethical and regulatory
standards.
Therapeutic Goods Administration (TGA):
Location: Australia
Role: TGA regulates therapeutic goods, including
medicines and medical devices, in Australia. It
assesses clinical trial applications and monitors trials
to ensure compliance with regulations.
Regulatory Requirements for Clinical Trials
Regulatory requirements for clinical trials are
essential to ensure the safety, efficacy, and ethical
conduct of trials involving human participants. These
requirements vary by country and region, but they
generally encompass several key aspects. Keep in
mind that these regulations may have evolved since
my last knowledge update in September 2021.
Always consult the latest official sources and
regulatory bodies for the most up-to-date information.
Here are some common regulatory requirements for
clinical trials:
Informed Consent: Participants must provide
informed consent before participating in a clinical
trial. They need to be fully informed about the trial's
purpose, procedures, potential risks and benefits, and
their rights as participants.
Ethics Review: Clinical trials involving human
participants must be reviewed and approved by an
independent ethics committee or institutional review
board (IRB) before they can begin. The review
assesses the trial's scientific validity, ethical
considerations, and participant protection measures.
Trial Protocol: A detailed trial protocol outlining the
study's objectives, methodology, participant
inclusion/exclusion criteria, interventions,
assessments, and statistical analysis plan must be
developed and followed.
Good Clinical Practice (GCP): GCP guidelines ensure
the ethical and scientific quality of clinical trials,
including the design, conduct, recording, and
reporting of trials. Adherence to GCP guidelines is
crucial for data integrity and participant safety.
Investigational New Drug (IND) Application or
Investigational Device Exemption (IDE) Application:
Before initiating a clinical trial, sponsors must often
submit an IND or IDE application to regulatory
authorities (like the FDA in the United States or the
EMA in Europe) for approval to test new drugs or
medical devices in humans.
Safety Monitoring and Reporting: Sponsors are
responsible for monitoring the safety of participants
throughout the trial and promptly reporting any
adverse events or serious adverse events to regulatory
authorities and ethics committees.
Quality Control and Assurance: Trials should be
conducted with rigorous quality control and assurance
measures to ensure accurate data collection,
documentation, and adherence to the protocol.
Trial Registration: Many countries require the
registration of clinical trials in public databases (such
as ClinicalTrials.gov) before enrollment begins. This
promotes transparency and helps prevent publication
bias.
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Data Handling and Recordkeeping: Accurate and
complete records of trial data, including source
documents, case report forms, and other relevant
documents, must be maintained.
Reporting and Publication: Sponsors are expected to
report trial results, regardless of outcome, in a timely
manner. Selective reporting of favorable outcomes
can lead to biased information.
Data Privacy and Protection: Participant data must be
handled confidentially and protected in accordance
with data privacy laws, such as the General Data
Protection Regulation (GDPR) in the European
Union.
Post-Trial Responsibilities: After the trial concludes,
sponsors must continue to monitor the long-term
safety and effectiveness of the intervention, and any
additional data should be reported as necessary.
Data Collection, Management, and Reporting
Data Collection:
Source Documents: Original documents, medical
records, and test results that provide evidence of trial-
related activities and observations.
Case Report Forms (CRFs): Structured forms used to
collect specific trial data, often in a standardized
format. Electronic CRFs (eCRFs) are increasingly
common.
Patient-Reported Outcomes (PROs): Data directly
reported by trial participants about their health status,
quality of life, and symptoms.
Clinical Assessments: Measurements, tests, and
observations conducted by healthcare professionals
according to the trial protocol.
Laboratory and Imaging Data: Results from medical
tests, such as blood tests and radiological imaging,
relevant to the trial's endpoints.
Data Management:
Data Entry and Verification: Data collected on CRFs
or eCRFs are entered into a secure database. Double
data entry and validation processes can help ensure
accuracy.
Data Validation: Automated checks and manual
reviews identify discrepancies, errors, or
inconsistencies in the data.
Data Monitoring: Ongoing review of data to ensure
protocol adherence, participant safety, and data
quality. Monitoring visits are conducted to verifydata
against source documents.
Query Management: Queries are generated when data
inconsistencies or missing information are identified.
Researchers and site staff address these queries to
rectify issues.
Audit Trails: Detailed records of data changes and
modifications, maintained for transparency and
accountability.
Data Security: Data is stored securely to prevent
unauthorized access or loss. Encryption and access
controls are employed.
Data Reporting:
Safety Reporting: Adverse events and serious adverse
events are reported according to regulatory
guidelines. A safety database tracks and analyzes
these events.
Interim Analysis: Periodic assessments of trial data
can be conducted to evaluate safety, efficacy, and the
potential need for early termination or protocol
modification.
Final Analysis: After trial completion, a
comprehensive analysis of collected data is performed
to draw conclusions about the intervention's effects.
Publication: Trial results are disseminated through
peer-reviewed journals, conference presentations, and
clinical trial registries, adhering to transparency
principles.
Data Sharing: Some trials require sharing of
anonymized data with other researchers for further
analysis or validation.
Regulatory Submissions: For drug and device trials,
data is compiled into a regulatory submission package
for review by health authorities.
Integrated Summary Reports: Summarize the trial's
results and data for regulatory submissions,
combining information from various sources.
Challenges and Considerations:
Data Integrity: Ensuring that data accurately
represents the trial's activities and outcomes,
minimizing errors and bias.
Electronic Data Capture (EDC): Transition from
paper-based data collection to electronic systems can
enhance efficiency and data quality.
Data Privacy: Adhering to data protection regulations
while maintaining participant confidentiality.
Cross-functional Collaboration: Effective
communication among researchers, data managers,
statisticians, and regulatory experts is crucial.
Protocol Adherence: Ensuring that data collected
aligns with the trial's predetermined methods and
endpoints.
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Data Standards: Using standardized formats and
terminology to facilitate data integration and analysis.
Good Clinical Practice (GCP) Guidelines
Good Clinical Practice (GCP) guidelines are
internationally recognized ethical and scientific
standards that ensure the design, conduct, monitoring,
recording, and reporting of clinical trials involving
human participants are consistent, reliable, and
ethically sound. These guidelines provide a
framework for maintaining participant safety, data
integrity, and the credibility of trial results. GCP
guidelines are essential for ensuring the quality and
ethical conduct of clinical research.
Key elements and principles of Good Clinical
Practice (GCP) guidelines:
Ethical Considerations:
Trials should be conducted in accordance with the
ethical principles set forth in the Declaration of
Helsinki and other relevant ethical standards.
The rights, safety, and well-being of trial participants
must take precedence over scientific and societal
interests.
Trial Design and Documentation:
Trials should be scientifically rigorous, well-
designed, and based on a detailed protocol that
outlines the trial's objectives, methods, and statistical
considerations.
All trial information should be documented
accurately, comprehensively, and contemporaneously.
Informed Consent:
Participants must provide informed, voluntary, and
documented consent to participate in the trial.
Participants should be provided with understandable
and relevant information about the trial, including
potential risks and benefits.
Participant Rights and Safety:
Participants' rights, safety, and well-being must be
protected throughout the trial.
Medical decisions related to participants' treatment
and participation in the trial should prioritize their
health and safety.
Investigational Product (Drug/Device) Management:
Investigational products should be manufactured,
handled, and stored in compliance with regulatory
requirements and the trial protocol.
Adequate records of the product's use and disposition
should be maintained.
Data Collection and Documentation:
All trial data should be collected, recorded, and
reported accurately, transparently, and promptly.
Source documents and case report forms should
accurately reflect trial events and participant
outcomes.
Monitoring and Quality Assurance:
Trials should be monitored by qualified individuals to
ensure protocol compliance, participant safety, and
data integrity.
Quality assurance processes should be in place to
prevent errors and inconsistencies.
Safety Reporting and Adverse Event Management:
Adverse events and their management should be
reported and documented promptly and accurately.
Serious adverse events should be reported to
regulatory authorities, ethics committees, and
investigators in a timely manner.
Record Keeping and Archiving:
All trial-related essential documents should be
retained and archived appropriately, allowing
traceability and verification.
Role of Ethics Committees and Regulatory
Authorities:
Ethical review committees (IRBs) and regulatory
authorities play a crucial role in reviewing,
approving, and monitoring trials.
Clinical Trial Protocol and Amendments:
Changes to the trial protocol should be documented,
communicated, and approved by relevant parties.
GCP guidelines are issued by various organizations,
including the International Council for Harmonisation
(ICH) and regulatory bodies like the U.S. Food and
Drug Administration (FDA) and the European
Medicines Agency (EMA). Adherence to GCP is
mandatory for clinical trials involving investigational
drugs, devices, and biologics, and it is highly
recommended for other types of clinical research as
well.
Strategies for Ensuring Regulatory Compliance
Ensuring regulatory compliance in clinical trials is of
paramount importance to uphold participant safety,
data integrity, and the reliability of trial results. To
achieve this, a comprehensive understanding of the
applicable regulations within the specific region or
country is essential. Collaborating with experienced
regulatory affairs professionals or consultants can
provide valuable guidance in navigating the complex
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regulatory landscape. Developing detailed and well-
structured trial protocols that encompass all aspects of
the study, from participant eligibility criteria to data
collection methods, is crucial for maintaining
consistency and adherence to regulatory standards.
Ethical considerations play a central role,
necessitating the approval of independent ethics
committees or institutional review boards (IRBs)
before trial initiation. This approval process ensures
the protection of participants' rights and adherence to
ethical guidelines. Establishing a robust informed
consent process, where participants are fully informed
about the trial's objectives, procedures, and potential
risks, is pivotal in ensuring their voluntary and well-
informed participation.
Qualified investigators and site staff are key
components in maintaining compliance. Proper
training and qualification ensure that the trial is
conducted in accordance with regulations and Good
Clinical Practice (GCP) guidelines, which are
internationally recognized standards for ethical
conduct and data integrity in clinical research.
Consistent documentation and record-keeping
practices are essential to capture trial-related activities
accurately, including participant interactions, adverse
events, and protocol deviations.
Active adherence to GCP guidelines guarantees the
scientific validity of the trial and its ethical conduct.
Regular monitoring visits and audits serve to confirm
that the trial is being executed as per the protocol,
regulations, and GCP standards. Establishing robust
data management processes guarantees the accuracy,
completeness, and reliability of data collected
throughout the trial.
Additionally, proactive safety reporting is essential,
ensuring that adverse events and serious adverse
events are reported promptly to regulatory authorities
and ethics committees. Transparent trial registration
and results reporting, regardless of the outcome,
contribute to the integrity of the research process.
Risk management plans help anticipate and mitigate
potential risks to participants and the study's integrity.
Maintaining open communication with regulatory
authorities and seeking their guidance and input as
needed can help ensure ongoing compliance. Lastly,
staying informed about evolving regulations and
guidelines is crucial to adapt practices and procedures
accordingly. By implementing these strategies,
clinical trial stakeholders can establish a robust
framework that ensures regulatory compliance,
participant safety, and the generation of reliable
scientific insights.
Future Trends in Regulatory Compliance
The landscape of regulatory compliance is on the
brink of transformation with the advent of various
future trends. The integration of technology is
becoming paramount, as digital solutions like
electronic data capture (EDC), electronic health
records (EHRs), and wearable devices are reshaping
data collection and monitoring in clinical trials. Real-
world evidence (RWE) is gaining prominence, as
regulators recognize the value of data from sources
like patient registries and wearable devices, providing
insights beyond traditional trial data.
The rise of decentralized clinical trials is altering trial
dynamics, leveraging telemedicine, remote
monitoring, and digital tools to enhance patient
convenience and diversify trial populations. Data
privacy and security have assumed greater
significance with stricter regulations such as GDPR,
mandating robust protection and responsible handling
of patient data. The integration of advanced analytics
and artificial intelligence (AI) is revolutionizing data
analysis, enabling real-time insights and proactive
safety monitoring.
Personalized medicine and biomarker-driven trials are
necessitating regulatory flexibility to accommodate
tailored treatments based on genetic and molecular
profiles. Efforts for global regulatory harmonization
are underway through initiatives like ICH, aiming to
align guidelines across regions and streamline
multinational trials. Patient engagement is gaining
traction, with regulatory agencies recognizing the
importance of patient input in trial design and
outcomes.
Real-time monitoring and auditing, facilitated by data
analytics and remote technologies, are poised to
enhance compliance oversight and issue
identification. Blockchain technology holds potential
to fortify data integrity, transparency, and traceability
across the trial lifecycle. These trends reflect a
shifting focus towards patient-centricity, data-driven
decision-making, and harnessing technology to
elevate regulatory compliance standards. Staying
attuned to these trends will be pivotal for
organizations navigating the evolving landscape of
regulatory compliance, especially within clinical
research and other regulated sectors.
Conclusion
The landscape of regulatory compliance is
continuously evolving, driven by a convergence of
technological advancements, patient-centered
approaches, and the need for data integrity. As
clinical trials become increasingly complex and
global, adherence to regulatory requirements remains
fundamental to safeguarding participant safety,
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maintaining data accuracy, and upholding the
credibility of trial results.
The future holds a spectrum of transformative trends,
from digital transformation and real-world evidence
integration to decentralized trials and AI-powered
analytics. These trends not only enhance efficiency
and data quality but also offer opportunities for
greater patient engagement and personalized
treatment approaches.
Adapting to these trends necessitates proactive
collaboration with regulatory experts, continuous
training of trial personnel, and agile strategies to
ensure seamless compliance across changing
regulatory landscapes. By embracing these future
trends, stakeholders in the clinical research arena can
foster a culture of innovation while upholding the
ethical principles and standards that underpin
regulatory compliance. As the future unfolds, the
synergybetween technology, patient engagement, and
regulatory compliance promises to reshape the
landscape of clinical trials for the better, ultimately
benefiting patients, researchers, and the broader
healthcare ecosystem.
References
[1] World Health Organization. (2016). Good
Clinical Practice (GCP) Guidelines. Retrieved
from https://www.who.int/ethics/research/en/
[2] International Council for Harmonisation of
Technical Requirements for Pharmaceuticals
for Human Use. (1996). Guideline for Good
Clinical Practice E6 (R2). Retrieved from
https://database.ich.org/sites/default/files/E6_R
2_Addendum.pdf
[3] European Medicines Agency. (2021). Clinical
Trials Regulation. Retrieved from
https://www.ema.europa.eu/en/human-
regulatory/research-development/clinical-
trials/clinical-trials-regulation
[4] Food and Drug Administration. (2021).
Investigational New Drug (IND) Application.
Retrieved from
https://www.fda.gov/drugs/types-
applications/investigational-new-drug-ind-
application
[5] European Medicines Agency. (2017). Guideline
on Good Pharmacovigilance Practices (GVP)
Module VI – Management and Reporting of
Adverse Reactions to Medicinal Products.
Retrieved from
https://www.ema.europa.eu/en/documents/scien
tific-guideline/draft-guideline-good-
pharmacovigilance-practices-gvp-module-vi-
management-reporting-adverse-
reactions_en.pdf
[6] ClinicalTrials.gov. (2021). About Clinical
Studies. Retrieved from
https://clinicaltrials.gov/ct2/about-studies/learn
[7] European Medicines Agency. (2018).
Reflection paper on investigational medicinal
products (IMPs) and market authorisation
procedures. Retrieved from
https://www.ema.europa.eu/en/documents/scien
tific-guideline/reflection-paper-investigational-
medicinal-products-imps-market-authorisation-
procedures_en.pdf
[8] U.S. National Library of Medicine. (2020).
Informed Consent. Retrieved from
https://www.ncbi.nlm.nih.gov/books/NBK5089
56/
[9] World Medical Association. (2013).
Declaration of Helsinki - Ethical Principles for
Medical Research Involving Human Subjects.
Retrieved from https://www.wma.net/what-we-
do/medical-ethics/declaration-of-helsinki/
[10] Pharmaceutical Research and Manufacturers of
America. (2018). Principles on Conduct of
Clinical Trials and Communication of Clinical
Trial Results. Retrieved from
https://www.phrma.org/-
/media/Project/PhRMA/PhRMA-Org/PhRMA-
Org/PDF/P-R/PhRMA-Principles-on-Clinical-
Trial-Information-Communication.pdf