SlideShare a Scribd company logo
Clinical Research Regulations
PG SEM I (MRA 103T)
Unit 1: Clinical Trial Protocol
Dimple Marathe
Assistant Professor
Sanjivani College of Pharmaceutical Education & Research
Kopargaon
Definition
• The protocol must be carefully designed to generate statistically and scientifically sound
answers to the questions that are being asked and meet the objective(s) of the study
• The objective(s) should also justify the risk; that is, the potential benefits (if any) of
participation in the study should outweigh the risks
Scientifically Justified
• Research involving humans should be scientifically justified and described in a clear,
detailed protocol
• “The experiment should be such as to yield fruitful results unprocurable by other methods
or means of study, and not random and unnecessary in nature” (The Nuremburg Code)
• “The design and performance of each experimental procedure involving human subjects
should be clearly formulated in an experimental protocol ” (Declaration of Helsinki)
Detailed Protocol. .
• A protocol “provides the background, rationale, and objective(s) of a biomedical research
project and describes its design, methodology, and organization, including ethical and
statistical considerations
• Some of these considerations may be provided in other documents referred to in the
protocol” (WHO Operational Guidelines for Ethics Committees that Review Biomedical
Research, Glossary)
Detailed Protocol
• General information
• Background information
• Description of the trial objectives and purpose
• Description of the trial design
• Criteria for inclusion, exclusion, and withdrawal of study subjects
• Treatment information
• Methods and timing for assessing, recording and analysing data gathered on the
investigational product
Detailed Protocol
• Methods for obtaining safety information, including plans for safety monitoring
• Description of the statistical methods to be employed
• Description of ethical considerations relating to the trial
• A statement related to permitting trial-related monitoring, audits, and inspection by the
sponsor, IEC/IRB, and regulators, including direct access to source data/documents
• Means for obtaining informed consent and communication of information to prospective
subjects
References
• https://www.who.int/medicines/areas/quality_safety/safety_efficacy/gcp1.pdf
Thank You

More Related Content

Similar to Unit 1 - Clinical Trial Protocol. Clinical research Regulation.pptx

Protocol writing
Protocol writing  Protocol writing
Protocol writing
Dr.Kavitha Vivek
 
Preparation of protocol
Preparation of protocolPreparation of protocol
Preparation of protocol
RushikeshTidake
 
Presentation on theme: "GCP (GOOD CLINICAL PRACTISE)"
Presentation on theme: "GCP (GOOD CLINICAL PRACTISE)"Presentation on theme: "GCP (GOOD CLINICAL PRACTISE)"
Presentation on theme: "GCP (GOOD CLINICAL PRACTISE)"
Nevin Francis
 
Different Types of Regulatory Documents
Different Types of Regulatory DocumentsDifferent Types of Regulatory Documents
Different Types of Regulatory Documents
Turacoz Skill Development Program
 
4. Unit-IV:- Clinical Trials.
4. Unit-IV:- Clinical Trials.4. Unit-IV:- Clinical Trials.
4. Unit-IV:- Clinical Trials.
Audumbar Mali
 
Cinical trial protocol writing
Cinical trial protocol writingCinical trial protocol writing
Cinical trial protocol writing
Urmila Aswar
 
Protocol Understanding_Katalyst HLS
Protocol Understanding_Katalyst HLSProtocol Understanding_Katalyst HLS
Protocol Understanding_Katalyst HLS
Katalyst HLS
 
Protocol Understanding_ Clinical Data Management_KatalystHLS
Protocol Understanding_ Clinical Data Management_KatalystHLSProtocol Understanding_ Clinical Data Management_KatalystHLS
Protocol Understanding_ Clinical Data Management_KatalystHLS
Katalyst HLS
 
Medical ethics
Medical ethicsMedical ethics
Medical ethics
NCRIMS, Meerut
 
Guidelines to the Preparation of document.pptx
Guidelines to the Preparation of document.pptxGuidelines to the Preparation of document.pptx
Guidelines to the Preparation of document.pptx
ShraddhaRaut43
 
ICH GCP GUIDELINES FOR CONDUCT OF TRIAL
ICH GCP GUIDELINES FOR CONDUCT OF TRIALICH GCP GUIDELINES FOR CONDUCT OF TRIAL
ICH GCP GUIDELINES FOR CONDUCT OF TRIAL
MOHAMMED FAHEEM KHAN
 
Clinical Trial_3_Fundamentals_Protocol Development.pptx
Clinical Trial_3_Fundamentals_Protocol Development.pptxClinical Trial_3_Fundamentals_Protocol Development.pptx
Clinical Trial_3_Fundamentals_Protocol Development.pptx
Ram Arya
 
ICH- GCP
ICH- GCPICH- GCP
ICH- GCP
Hima Haridasan
 
Gcp
GcpGcp
Clinical Trial Protocol.pptx
Clinical Trial Protocol.pptxClinical Trial Protocol.pptx
Clinical Trial Protocol.pptx
Venugopal N
 
Indian gcp guidelines[647]
Indian gcp guidelines[647]Indian gcp guidelines[647]
Indian gcp guidelines[647]
AkhileshAkki6
 
Clinical research protocols
Clinical research protocolsClinical research protocols
Clinical research protocols
MouryaDeep
 
NISHA YADAV ROLLNO. 2116102 PRESENTATION ON DEVELOPING CLINICAL TRIAL PROTOCO...
NISHA YADAV ROLLNO. 2116102 PRESENTATION ON DEVELOPING CLINICAL TRIAL PROTOCO...NISHA YADAV ROLLNO. 2116102 PRESENTATION ON DEVELOPING CLINICAL TRIAL PROTOCO...
NISHA YADAV ROLLNO. 2116102 PRESENTATION ON DEVELOPING CLINICAL TRIAL PROTOCO...
CGC, LANDRAN
 
PV seminar.pptx
PV seminar.pptxPV seminar.pptx
PV seminar.pptx
IshuHari
 
ROLES AND RESPONSIBLITIES OF CLINICAL TRIAL PERSONNEL-INVESTIGATOR.pptx
ROLES AND RESPONSIBLITIES OF CLINICAL TRIAL PERSONNEL-INVESTIGATOR.pptxROLES AND RESPONSIBLITIES OF CLINICAL TRIAL PERSONNEL-INVESTIGATOR.pptx
ROLES AND RESPONSIBLITIES OF CLINICAL TRIAL PERSONNEL-INVESTIGATOR.pptx
E Poovarasan
 

Similar to Unit 1 - Clinical Trial Protocol. Clinical research Regulation.pptx (20)

Protocol writing
Protocol writing  Protocol writing
Protocol writing
 
Preparation of protocol
Preparation of protocolPreparation of protocol
Preparation of protocol
 
Presentation on theme: "GCP (GOOD CLINICAL PRACTISE)"
Presentation on theme: "GCP (GOOD CLINICAL PRACTISE)"Presentation on theme: "GCP (GOOD CLINICAL PRACTISE)"
Presentation on theme: "GCP (GOOD CLINICAL PRACTISE)"
 
Different Types of Regulatory Documents
Different Types of Regulatory DocumentsDifferent Types of Regulatory Documents
Different Types of Regulatory Documents
 
4. Unit-IV:- Clinical Trials.
4. Unit-IV:- Clinical Trials.4. Unit-IV:- Clinical Trials.
4. Unit-IV:- Clinical Trials.
 
Cinical trial protocol writing
Cinical trial protocol writingCinical trial protocol writing
Cinical trial protocol writing
 
Protocol Understanding_Katalyst HLS
Protocol Understanding_Katalyst HLSProtocol Understanding_Katalyst HLS
Protocol Understanding_Katalyst HLS
 
Protocol Understanding_ Clinical Data Management_KatalystHLS
Protocol Understanding_ Clinical Data Management_KatalystHLSProtocol Understanding_ Clinical Data Management_KatalystHLS
Protocol Understanding_ Clinical Data Management_KatalystHLS
 
Medical ethics
Medical ethicsMedical ethics
Medical ethics
 
Guidelines to the Preparation of document.pptx
Guidelines to the Preparation of document.pptxGuidelines to the Preparation of document.pptx
Guidelines to the Preparation of document.pptx
 
ICH GCP GUIDELINES FOR CONDUCT OF TRIAL
ICH GCP GUIDELINES FOR CONDUCT OF TRIALICH GCP GUIDELINES FOR CONDUCT OF TRIAL
ICH GCP GUIDELINES FOR CONDUCT OF TRIAL
 
Clinical Trial_3_Fundamentals_Protocol Development.pptx
Clinical Trial_3_Fundamentals_Protocol Development.pptxClinical Trial_3_Fundamentals_Protocol Development.pptx
Clinical Trial_3_Fundamentals_Protocol Development.pptx
 
ICH- GCP
ICH- GCPICH- GCP
ICH- GCP
 
Gcp
GcpGcp
Gcp
 
Clinical Trial Protocol.pptx
Clinical Trial Protocol.pptxClinical Trial Protocol.pptx
Clinical Trial Protocol.pptx
 
Indian gcp guidelines[647]
Indian gcp guidelines[647]Indian gcp guidelines[647]
Indian gcp guidelines[647]
 
Clinical research protocols
Clinical research protocolsClinical research protocols
Clinical research protocols
 
NISHA YADAV ROLLNO. 2116102 PRESENTATION ON DEVELOPING CLINICAL TRIAL PROTOCO...
NISHA YADAV ROLLNO. 2116102 PRESENTATION ON DEVELOPING CLINICAL TRIAL PROTOCO...NISHA YADAV ROLLNO. 2116102 PRESENTATION ON DEVELOPING CLINICAL TRIAL PROTOCO...
NISHA YADAV ROLLNO. 2116102 PRESENTATION ON DEVELOPING CLINICAL TRIAL PROTOCO...
 
PV seminar.pptx
PV seminar.pptxPV seminar.pptx
PV seminar.pptx
 
ROLES AND RESPONSIBLITIES OF CLINICAL TRIAL PERSONNEL-INVESTIGATOR.pptx
ROLES AND RESPONSIBLITIES OF CLINICAL TRIAL PERSONNEL-INVESTIGATOR.pptxROLES AND RESPONSIBLITIES OF CLINICAL TRIAL PERSONNEL-INVESTIGATOR.pptx
ROLES AND RESPONSIBLITIES OF CLINICAL TRIAL PERSONNEL-INVESTIGATOR.pptx
 

More from Dimple Marathe

Post marketing surveillance in Japan, legislation and.pptx
Post marketing surveillance in Japan, legislation and.pptxPost marketing surveillance in Japan, legislation and.pptx
Post marketing surveillance in Japan, legislation and.pptx
Dimple Marathe
 
Drug Regulatory Affairs, European Food Safety Authority.pptx
Drug Regulatory Affairs, European Food Safety Authority.pptxDrug Regulatory Affairs, European Food Safety Authority.pptx
Drug Regulatory Affairs, European Food Safety Authority.pptx
Dimple Marathe
 
Nutritional labelling & European Regulation on Novel Foods and Novel Food Ing...
Nutritional labelling & European Regulation on Novel Foods and Novel Food Ing...Nutritional labelling & European Regulation on Novel Foods and Novel Food Ing...
Nutritional labelling & European Regulation on Novel Foods and Novel Food Ing...
Dimple Marathe
 
Emerging Markets Documentation for Drug Regulatory Affairs
Emerging Markets Documentation for Drug Regulatory AffairsEmerging Markets Documentation for Drug Regulatory Affairs
Emerging Markets Documentation for Drug Regulatory Affairs
Dimple Marathe
 
MRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptx
MRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptxMRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptx
MRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptx
Dimple Marathe
 
Unit 1 Part 1Drug Development Process - Part 1.pptx
Unit 1  Part 1Drug Development Process - Part 1.pptxUnit 1  Part 1Drug Development Process - Part 1.pptx
Unit 1 Part 1Drug Development Process - Part 1.pptx
Dimple Marathe
 
Unit 1 - Part 2 Drug Development Process - Part 2.pptx
Unit 1 - Part 2  Drug Development Process - Part 2.pptxUnit 1 - Part 2  Drug Development Process - Part 2.pptx
Unit 1 - Part 2 Drug Development Process - Part 2.pptx
Dimple Marathe
 
Phases of Clinical Trials. Clinical Research Regulation
Phases of Clinical Trials. Clinical Research RegulationPhases of Clinical Trials. Clinical Research Regulation
Phases of Clinical Trials. Clinical Research Regulation
Dimple Marathe
 
CGMP drug regulatory affairs Current good manufacturing practices
CGMP drug regulatory affairs Current good manufacturing practicesCGMP drug regulatory affairs Current good manufacturing practices
CGMP drug regulatory affairs Current good manufacturing practices
Dimple Marathe
 
Upld narcotics and psychotropic dimple marathe.pptx
Upld narcotics and psychotropic dimple marathe.pptxUpld narcotics and psychotropic dimple marathe.pptx
Upld narcotics and psychotropic dimple marathe.pptx
Dimple Marathe
 
upld medicinal and toilet prep dimple marathe.pptx
upld medicinal and toilet prep dimple marathe.pptxupld medicinal and toilet prep dimple marathe.pptx
upld medicinal and toilet prep dimple marathe.pptx
Dimple Marathe
 
Upld Labelling requirement & label claim for dietary supplements.pptx
Upld Labelling requirement & label claim for dietary supplements.pptxUpld Labelling requirement & label claim for dietary supplements.pptx
Upld Labelling requirement & label claim for dietary supplements.pptx
Dimple Marathe
 
cgmp presentation upld.pptx
cgmp presentation upld.pptxcgmp presentation upld.pptx
cgmp presentation upld.pptx
Dimple Marathe
 
Blood and Blood product regulation in india
Blood and Blood product regulation in indiaBlood and Blood product regulation in india
Blood and Blood product regulation in india
Dimple Marathe
 

More from Dimple Marathe (14)

Post marketing surveillance in Japan, legislation and.pptx
Post marketing surveillance in Japan, legislation and.pptxPost marketing surveillance in Japan, legislation and.pptx
Post marketing surveillance in Japan, legislation and.pptx
 
Drug Regulatory Affairs, European Food Safety Authority.pptx
Drug Regulatory Affairs, European Food Safety Authority.pptxDrug Regulatory Affairs, European Food Safety Authority.pptx
Drug Regulatory Affairs, European Food Safety Authority.pptx
 
Nutritional labelling & European Regulation on Novel Foods and Novel Food Ing...
Nutritional labelling & European Regulation on Novel Foods and Novel Food Ing...Nutritional labelling & European Regulation on Novel Foods and Novel Food Ing...
Nutritional labelling & European Regulation on Novel Foods and Novel Food Ing...
 
Emerging Markets Documentation for Drug Regulatory Affairs
Emerging Markets Documentation for Drug Regulatory AffairsEmerging Markets Documentation for Drug Regulatory Affairs
Emerging Markets Documentation for Drug Regulatory Affairs
 
MRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptx
MRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptxMRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptx
MRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptx
 
Unit 1 Part 1Drug Development Process - Part 1.pptx
Unit 1  Part 1Drug Development Process - Part 1.pptxUnit 1  Part 1Drug Development Process - Part 1.pptx
Unit 1 Part 1Drug Development Process - Part 1.pptx
 
Unit 1 - Part 2 Drug Development Process - Part 2.pptx
Unit 1 - Part 2  Drug Development Process - Part 2.pptxUnit 1 - Part 2  Drug Development Process - Part 2.pptx
Unit 1 - Part 2 Drug Development Process - Part 2.pptx
 
Phases of Clinical Trials. Clinical Research Regulation
Phases of Clinical Trials. Clinical Research RegulationPhases of Clinical Trials. Clinical Research Regulation
Phases of Clinical Trials. Clinical Research Regulation
 
CGMP drug regulatory affairs Current good manufacturing practices
CGMP drug regulatory affairs Current good manufacturing practicesCGMP drug regulatory affairs Current good manufacturing practices
CGMP drug regulatory affairs Current good manufacturing practices
 
Upld narcotics and psychotropic dimple marathe.pptx
Upld narcotics and psychotropic dimple marathe.pptxUpld narcotics and psychotropic dimple marathe.pptx
Upld narcotics and psychotropic dimple marathe.pptx
 
upld medicinal and toilet prep dimple marathe.pptx
upld medicinal and toilet prep dimple marathe.pptxupld medicinal and toilet prep dimple marathe.pptx
upld medicinal and toilet prep dimple marathe.pptx
 
Upld Labelling requirement & label claim for dietary supplements.pptx
Upld Labelling requirement & label claim for dietary supplements.pptxUpld Labelling requirement & label claim for dietary supplements.pptx
Upld Labelling requirement & label claim for dietary supplements.pptx
 
cgmp presentation upld.pptx
cgmp presentation upld.pptxcgmp presentation upld.pptx
cgmp presentation upld.pptx
 
Blood and Blood product regulation in india
Blood and Blood product regulation in indiaBlood and Blood product regulation in india
Blood and Blood product regulation in india
 

Recently uploaded

Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...
Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...
Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...
FFragrant
 
BCBR MCQs with Answers.pdf for exam for NMC promotions
BCBR MCQs with Answers.pdf for exam for NMC promotionsBCBR MCQs with Answers.pdf for exam for NMC promotions
BCBR MCQs with Answers.pdf for exam for NMC promotions
sathya swaroop patnaik
 
Text Book of Operation Theater Nursing OT Nursing
Text Book of Operation Theater Nursing OT NursingText Book of Operation Theater Nursing OT Nursing
Text Book of Operation Theater Nursing OT Nursing
BP KOIRALA INSTITUTE OF HELATH SCIENCS,, NEPAL
 
Text Book of Emergency Disaster and Trauma Nursing Book
Text Book of Emergency Disaster and Trauma Nursing  BookText Book of Emergency Disaster and Trauma Nursing  Book
Text Book of Emergency Disaster and Trauma Nursing Book
BP KOIRALA INSTITUTE OF HELATH SCIENCS,, NEPAL
 
Hemodialysis: Chapter 11, Venous Catheter - Basics, Insertion, Use and Care -...
Hemodialysis: Chapter 11, Venous Catheter - Basics, Insertion, Use and Care -...Hemodialysis: Chapter 11, Venous Catheter - Basics, Insertion, Use and Care -...
Hemodialysis: Chapter 11, Venous Catheter - Basics, Insertion, Use and Care -...
NephroTube - Dr.Gawad
 
medical law and ethics presentation .ppt
medical law and ethics presentation .pptmedical law and ethics presentation .ppt
medical law and ethics presentation .ppt
PseudoPocket
 
Prevention of Cruelty to animals act 1960
Prevention of Cruelty to animals act 1960Prevention of Cruelty to animals act 1960
Prevention of Cruelty to animals act 1960
PratibhaSonawane5
 
ONYDA XR clonidine liquid preparation by Dr. Amrutha
ONYDA XR clonidine liquid preparation by Dr. AmruthaONYDA XR clonidine liquid preparation by Dr. Amrutha
ONYDA XR clonidine liquid preparation by Dr. Amrutha
Amrutha Gudimetla
 
First-Aid-Made-Easy-Training-Presentation (1).pptx
First-Aid-Made-Easy-Training-Presentation (1).pptxFirst-Aid-Made-Easy-Training-Presentation (1).pptx
First-Aid-Made-Easy-Training-Presentation (1).pptx
RichardRMThod
 
Lymphoma Made Easy , New Teaching Lectures
Lymphoma Made Easy , New Teaching LecturesLymphoma Made Easy , New Teaching Lectures
Lymphoma Made Easy , New Teaching Lectures
MiadAlsulami
 
Stepping Forward to Transform MCL Management: Guidance on the Selection and U...
Stepping Forward to Transform MCL Management: Guidance on the Selection and U...Stepping Forward to Transform MCL Management: Guidance on the Selection and U...
Stepping Forward to Transform MCL Management: Guidance on the Selection and U...
PVI, PeerView Institute for Medical Education
 
Heart Valves and Heart Sounds -Congenital & valvular heart disease.pdf
Heart Valves and Heart Sounds -Congenital & valvular heart disease.pdfHeart Valves and Heart Sounds -Congenital & valvular heart disease.pdf
Heart Valves and Heart Sounds -Congenital & valvular heart disease.pdf
MedicoseAcademics
 
2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf
2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf
2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf
CarriePoppy
 
Prostatitis Severity- How to Determine if You Have Mild Symptoms.pptx
Prostatitis Severity- How to Determine if You Have Mild Symptoms.pptxProstatitis Severity- How to Determine if You Have Mild Symptoms.pptx
Prostatitis Severity- How to Determine if You Have Mild Symptoms.pptx
AmandaChou9
 
Bangalore @Girls @Call WhatsApp Numbers 🫦0000XX0000🫦 List For Friendship Girl...
Bangalore @Girls @Call WhatsApp Numbers 🫦0000XX0000🫦 List For Friendship Girl...Bangalore @Girls @Call WhatsApp Numbers 🫦0000XX0000🫦 List For Friendship Girl...
Bangalore @Girls @Call WhatsApp Numbers 🫦0000XX0000🫦 List For Friendship Girl...
paridubey2024#G05
 
Approach to Head Injuiry, Intracranial Pressure Measurement and Management.pptx
Approach to Head Injuiry, Intracranial Pressure Measurement and Management.pptxApproach to Head Injuiry, Intracranial Pressure Measurement and Management.pptx
Approach to Head Injuiry, Intracranial Pressure Measurement and Management.pptx
Bipul Thakur
 
World Population Day 2024_Overview_Dr Bijan Das
World Population Day 2024_Overview_Dr Bijan DasWorld Population Day 2024_Overview_Dr Bijan Das
World Population Day 2024_Overview_Dr Bijan Das
srmnchatripura
 
MEDICAL PROFESSIONALISM Class of compassionate care
MEDICAL PROFESSIONALISM Class of compassionate careMEDICAL PROFESSIONALISM Class of compassionate care
MEDICAL PROFESSIONALISM Class of compassionate care
Debre Berhan University
 
General Endocrinology and mechanism of action of hormones
General Endocrinology and mechanism of action of hormonesGeneral Endocrinology and mechanism of action of hormones
General Endocrinology and mechanism of action of hormones
MedicoseAcademics
 
2nd week of Human development .embryology
2nd week of Human development .embryology2nd week of Human development .embryology
2nd week of Human development .embryology
Mithilesh Chaurasia
 

Recently uploaded (20)

Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...
Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...
Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...
 
BCBR MCQs with Answers.pdf for exam for NMC promotions
BCBR MCQs with Answers.pdf for exam for NMC promotionsBCBR MCQs with Answers.pdf for exam for NMC promotions
BCBR MCQs with Answers.pdf for exam for NMC promotions
 
Text Book of Operation Theater Nursing OT Nursing
Text Book of Operation Theater Nursing OT NursingText Book of Operation Theater Nursing OT Nursing
Text Book of Operation Theater Nursing OT Nursing
 
Text Book of Emergency Disaster and Trauma Nursing Book
Text Book of Emergency Disaster and Trauma Nursing  BookText Book of Emergency Disaster and Trauma Nursing  Book
Text Book of Emergency Disaster and Trauma Nursing Book
 
Hemodialysis: Chapter 11, Venous Catheter - Basics, Insertion, Use and Care -...
Hemodialysis: Chapter 11, Venous Catheter - Basics, Insertion, Use and Care -...Hemodialysis: Chapter 11, Venous Catheter - Basics, Insertion, Use and Care -...
Hemodialysis: Chapter 11, Venous Catheter - Basics, Insertion, Use and Care -...
 
medical law and ethics presentation .ppt
medical law and ethics presentation .pptmedical law and ethics presentation .ppt
medical law and ethics presentation .ppt
 
Prevention of Cruelty to animals act 1960
Prevention of Cruelty to animals act 1960Prevention of Cruelty to animals act 1960
Prevention of Cruelty to animals act 1960
 
ONYDA XR clonidine liquid preparation by Dr. Amrutha
ONYDA XR clonidine liquid preparation by Dr. AmruthaONYDA XR clonidine liquid preparation by Dr. Amrutha
ONYDA XR clonidine liquid preparation by Dr. Amrutha
 
First-Aid-Made-Easy-Training-Presentation (1).pptx
First-Aid-Made-Easy-Training-Presentation (1).pptxFirst-Aid-Made-Easy-Training-Presentation (1).pptx
First-Aid-Made-Easy-Training-Presentation (1).pptx
 
Lymphoma Made Easy , New Teaching Lectures
Lymphoma Made Easy , New Teaching LecturesLymphoma Made Easy , New Teaching Lectures
Lymphoma Made Easy , New Teaching Lectures
 
Stepping Forward to Transform MCL Management: Guidance on the Selection and U...
Stepping Forward to Transform MCL Management: Guidance on the Selection and U...Stepping Forward to Transform MCL Management: Guidance on the Selection and U...
Stepping Forward to Transform MCL Management: Guidance on the Selection and U...
 
Heart Valves and Heart Sounds -Congenital & valvular heart disease.pdf
Heart Valves and Heart Sounds -Congenital & valvular heart disease.pdfHeart Valves and Heart Sounds -Congenital & valvular heart disease.pdf
Heart Valves and Heart Sounds -Congenital & valvular heart disease.pdf
 
2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf
2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf
2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf
 
Prostatitis Severity- How to Determine if You Have Mild Symptoms.pptx
Prostatitis Severity- How to Determine if You Have Mild Symptoms.pptxProstatitis Severity- How to Determine if You Have Mild Symptoms.pptx
Prostatitis Severity- How to Determine if You Have Mild Symptoms.pptx
 
Bangalore @Girls @Call WhatsApp Numbers 🫦0000XX0000🫦 List For Friendship Girl...
Bangalore @Girls @Call WhatsApp Numbers 🫦0000XX0000🫦 List For Friendship Girl...Bangalore @Girls @Call WhatsApp Numbers 🫦0000XX0000🫦 List For Friendship Girl...
Bangalore @Girls @Call WhatsApp Numbers 🫦0000XX0000🫦 List For Friendship Girl...
 
Approach to Head Injuiry, Intracranial Pressure Measurement and Management.pptx
Approach to Head Injuiry, Intracranial Pressure Measurement and Management.pptxApproach to Head Injuiry, Intracranial Pressure Measurement and Management.pptx
Approach to Head Injuiry, Intracranial Pressure Measurement and Management.pptx
 
World Population Day 2024_Overview_Dr Bijan Das
World Population Day 2024_Overview_Dr Bijan DasWorld Population Day 2024_Overview_Dr Bijan Das
World Population Day 2024_Overview_Dr Bijan Das
 
MEDICAL PROFESSIONALISM Class of compassionate care
MEDICAL PROFESSIONALISM Class of compassionate careMEDICAL PROFESSIONALISM Class of compassionate care
MEDICAL PROFESSIONALISM Class of compassionate care
 
General Endocrinology and mechanism of action of hormones
General Endocrinology and mechanism of action of hormonesGeneral Endocrinology and mechanism of action of hormones
General Endocrinology and mechanism of action of hormones
 
2nd week of Human development .embryology
2nd week of Human development .embryology2nd week of Human development .embryology
2nd week of Human development .embryology
 

Unit 1 - Clinical Trial Protocol. Clinical research Regulation.pptx

  • 1. Clinical Research Regulations PG SEM I (MRA 103T) Unit 1: Clinical Trial Protocol Dimple Marathe Assistant Professor Sanjivani College of Pharmaceutical Education & Research Kopargaon
  • 2. Definition • The protocol must be carefully designed to generate statistically and scientifically sound answers to the questions that are being asked and meet the objective(s) of the study • The objective(s) should also justify the risk; that is, the potential benefits (if any) of participation in the study should outweigh the risks
  • 3. Scientifically Justified • Research involving humans should be scientifically justified and described in a clear, detailed protocol • “The experiment should be such as to yield fruitful results unprocurable by other methods or means of study, and not random and unnecessary in nature” (The Nuremburg Code) • “The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol ” (Declaration of Helsinki)
  • 4. Detailed Protocol. . • A protocol “provides the background, rationale, and objective(s) of a biomedical research project and describes its design, methodology, and organization, including ethical and statistical considerations • Some of these considerations may be provided in other documents referred to in the protocol” (WHO Operational Guidelines for Ethics Committees that Review Biomedical Research, Glossary)
  • 5. Detailed Protocol • General information • Background information • Description of the trial objectives and purpose • Description of the trial design • Criteria for inclusion, exclusion, and withdrawal of study subjects • Treatment information • Methods and timing for assessing, recording and analysing data gathered on the investigational product
  • 6. Detailed Protocol • Methods for obtaining safety information, including plans for safety monitoring • Description of the statistical methods to be employed • Description of ethical considerations relating to the trial • A statement related to permitting trial-related monitoring, audits, and inspection by the sponsor, IEC/IRB, and regulators, including direct access to source data/documents • Means for obtaining informed consent and communication of information to prospective subjects