Samenvatting Clinical Drug Research
2022-2023
Master: Klinisch wetenschappelijk
onderzoek
Biomedische Wetenschappen
, Stuvia - Koop en Verkoop de Beste Samenvattingen
Open vragen + MCQ
Je kan ICH-GCP certificaat krijgen om clinical work in master thesis uit te voeren. “Example of examination
questions” les 1 zijn alle examinatievragen die ze stellen op de test voor het certificaat. (was echt super easy)
Inhoud
Les 1: ICH-GCP ................................................................................................................................................................... 7
Part 1: Introduction to ICH-GCP .................................................................................................................................... 7
Voorbeeld examenvragen ......................................................................................................................................... 7
Part 2: Legislation for clinical research ....................................................................................................................... 10
Part 3: Terminology on Pharmacovigilance ................................................................................................................ 10
Part 4: Definition of Clinical research ......................................................................................................................... 11
Part 5: 13 principles of ICH-GCP.................................................................................................................................. 13
Part 6: Role of IRB’s and IEC’s ..................................................................................................................................... 14
Part 7: How to obtain an informed consent ............................................................................................................... 15
Part 8: Quality management of clinical research ........................................................................................................ 15
Part 9: Translation of ICH-GCP principles into documents related to clinical research ............................................. 16
Part 10: Study protocol ............................................................................................................................................... 17
Part 11: Log forms ....................................................................................................................................................... 18
Part 12: Case report forms CRF ................................................................................................................................... 20
Part 13: investigator brochure .................................................................................................................................... 22
Part 14: Other relevant documents ............................................................................................................................ 22
Responsibilities ........................................................................................................................................................... 23
Part 15: Responsibilities of sponsor ............................................................................................................................ 23
Part 16: Responsibilities of CRO = contract research organization ............................................................................ 23
Part 17: Responsibilities of CRA: clinical research associate/ CTA: clinical trial administrator .................................. 23
Part 18: Responsibilities of clinical data management (sponsor) ............................................................................... 24
Part 19: Responsibilities of principal investigator....................................................................................................... 24
Part 20: Involvement of study coordinator and/or study nurse = investigator team ................................................ 24
Part 21: Mutual responsibilities between sponsor and investigator team ................................................................ 25
Part 22: Skills involved in clinical research.................................................................................................................. 25
Part 23: Essential documents within TMF trial master file and ISF investigator site file ............................................ 26
Part 24: Clinical investigation of medical devices for human subjects ....................................................................... 28
Les 2: Patrick Cras: Ethics committee => examen = general knowledge, enkel grote lijnen in MCQ ............................. 30
What is an ethics committee ...................................................................................................................................... 30
Why ethics committees .............................................................................................................................................. 30
Ethical review .............................................................................................................................................................. 30
Clinical ethics versus research ethics .......................................................................................................................... 30
Protection of subject................................................................................................................................................... 31
Basic texts on ethics in clinical research ..................................................................................................................... 31
Nuremberg Code ......................................................................................................................................................... 31
Wil jij €76 per
Dit document is auteursrechtelijk beschermd, het verspreiden van dit document is strafbaar. maand verdienen?
, Stuvia - Koop en Verkoop de Beste Samenvattingen
The declaration of Helsinki (2013) .............................................................................................................................. 31
Additional guidelines .................................................................................................................................................. 31
Clinical trial regulation ................................................................................................................................................ 32
Functie ethics committee: ICH guidelines................................................................................................................... 33
Written policies and procedures................................................................................................................................. 33
Participation in clinical trials ....................................................................................................................................... 34
Negative advice ........................................................................................................................................................... 34
Faq’s ............................................................................................................................................................................ 34
Financial aspects of clinical trials ................................................................................................................................ 35
Follow-up .................................................................................................................................................................... 35
Ethics of EC/IRB ........................................................................................................................................................... 35
Potential conflict of interest ....................................................................................................................................... 36
Dealing with conflicts of interest ................................................................................................................................ 36
Quality of ethical review ............................................................................................................................................. 36
Quality assurance metrics ........................................................................................................................................... 36
Quality of decision making .......................................................................................................................................... 37
Current status of CTR clinical trial regulation ............................................................................................................. 37
Low intervention clinical trial...................................................................................................................................... 37
Research challenged by GDPR?................................................................................................................................... 38
Data storage and handling .......................................................................................................................................... 38
Difficulty in identifying (secondary) research purposes in the future in advance ...................................................... 38
Conclusions ................................................................................................................................................................. 38
Les 2.1 Statistics in clinical trials: Does sample size really matter for a clinical trial? .................................................... 40
1. Circle of research ................................................................................................................................................ 40
2. What is hypothesis testing? ................................................................................................................................ 40
3. Statistical methods.............................................................................................................................................. 40
4. What is a sample size? ........................................................................................................................................ 41
5. How large should the sample be? ....................................................................................................................... 41
6. Significance level α and power (1 − β) ................................................................................................................ 41
7. Fundamental points ............................................................................................................................................ 42
8. Treatment A or B? ............................................................................................................................................... 42
9. How to get sample size – rough idea .................................................................................................................. 43
10. What is needed for sample size calculation? .................................................................................................. 43
11. Sample size calculation ................................................................................................................................... 43
12. Simple formula for difference in proportions ................................................................................................. 44
13. Exercise ........................................................................................................................................................... 44
14. Effect size ↔ sample size per group .............................................................................................................. 44
15. Some further topics ........................................................................................................................................ 45
16. Summary ......................................................................................................................................................... 45
Wil jij €76 per
Dit document is auteursrechtelijk beschermd, het verspreiden van dit document is strafbaar. maand verdienen?
, Stuvia - Koop en Verkoop de Beste Samenvattingen
Les 3: Start up and conduct of a clinical trial (open and general questions), Role, tasks, responsibilities of CRO,
CRA, monitor, sponsor, investigator.......................................................................................................................... 46
Definitions ................................................................................................................................................................... 46
Medical device development timeline........................................................................................................................ 47
Main players................................................................................................................................................................ 48
Set-up and conduct of a clinical trial:.......................................................................................................................... 49
Material requirements – sponsor and investigator .................................................................................................... 49
Clinical trials start-up and conduct ............................................................................................................................. 52
Safety reporting .......................................................................................................................................................... 56
Les 4: Study design => multiple choice questions, geen details, geen historische details, de belangrijke concepten
goed kennen ................................................................................................................................................................... 59
Introduction: towards the gold standard.................................................................................................................... 59
Historical examples ................................................................................................................................................. 59
Why clinical trials? ...................................................................................................................................................... 59
Choosing the right timing............................................................................................................................................ 59
Study protocol ............................................................................................................................................................. 59
RCT = golden standard for clinical trials = randomized controlled trials .................................................................... 60
Randomised double-blind placebo-controlled clinical trial = golden standard ..................................................... 61
Posing the right question ............................................................................................................................................ 62
Choosing the right population .................................................................................................................................... 63
Defining the treatment schedule ................................................................................................................................ 64
Special designs ............................................................................................................................................................ 65
Les 4.2 Data management (geen slides van, wel document van wat te kennen) .......................................................... 65
Les 4.3 Data analysis ....................................................................................................................................................... 68
Clinical trial Reporting ................................................................................................................................................. 68
Les 4.4 Placebo................................................................................................................................................................ 69
History ......................................................................................................................................................................... 69
Placebo-RCT-Double blind .......................................................................................................................................... 69
From decoy to powerfull to powerless ....................................................................................................................... 70
Hoe lang werkt placebo? ............................................................................................................................................ 70
What results are most important?.............................................................................................................................. 70
Natural history ............................................................................................................................................................ 71
Regression to the mean .............................................................................................................................................. 71
Conditioning ................................................................................................................................................................ 71
Hawthorne effect ........................................................................................................................................................ 71
Chirurgische placebo ................................................................................................................................................... 71
Special placebo’s ......................................................................................................................................................... 71
Nocebo in clinical trials ............................................................................................................................................... 71
Pharmacology van placebo effecten ........................................................................................................................... 72
Vooroordeel in interpretatie van klinische trials ........................................................................................................ 72
Wil jij €76 per
Dit document is auteursrechtelijk beschermd, het verspreiden van dit document is strafbaar. maand verdienen?
2022-2023
Master: Klinisch wetenschappelijk
onderzoek
Biomedische Wetenschappen
, Stuvia - Koop en Verkoop de Beste Samenvattingen
Open vragen + MCQ
Je kan ICH-GCP certificaat krijgen om clinical work in master thesis uit te voeren. “Example of examination
questions” les 1 zijn alle examinatievragen die ze stellen op de test voor het certificaat. (was echt super easy)
Inhoud
Les 1: ICH-GCP ................................................................................................................................................................... 7
Part 1: Introduction to ICH-GCP .................................................................................................................................... 7
Voorbeeld examenvragen ......................................................................................................................................... 7
Part 2: Legislation for clinical research ....................................................................................................................... 10
Part 3: Terminology on Pharmacovigilance ................................................................................................................ 10
Part 4: Definition of Clinical research ......................................................................................................................... 11
Part 5: 13 principles of ICH-GCP.................................................................................................................................. 13
Part 6: Role of IRB’s and IEC’s ..................................................................................................................................... 14
Part 7: How to obtain an informed consent ............................................................................................................... 15
Part 8: Quality management of clinical research ........................................................................................................ 15
Part 9: Translation of ICH-GCP principles into documents related to clinical research ............................................. 16
Part 10: Study protocol ............................................................................................................................................... 17
Part 11: Log forms ....................................................................................................................................................... 18
Part 12: Case report forms CRF ................................................................................................................................... 20
Part 13: investigator brochure .................................................................................................................................... 22
Part 14: Other relevant documents ............................................................................................................................ 22
Responsibilities ........................................................................................................................................................... 23
Part 15: Responsibilities of sponsor ............................................................................................................................ 23
Part 16: Responsibilities of CRO = contract research organization ............................................................................ 23
Part 17: Responsibilities of CRA: clinical research associate/ CTA: clinical trial administrator .................................. 23
Part 18: Responsibilities of clinical data management (sponsor) ............................................................................... 24
Part 19: Responsibilities of principal investigator....................................................................................................... 24
Part 20: Involvement of study coordinator and/or study nurse = investigator team ................................................ 24
Part 21: Mutual responsibilities between sponsor and investigator team ................................................................ 25
Part 22: Skills involved in clinical research.................................................................................................................. 25
Part 23: Essential documents within TMF trial master file and ISF investigator site file ............................................ 26
Part 24: Clinical investigation of medical devices for human subjects ....................................................................... 28
Les 2: Patrick Cras: Ethics committee => examen = general knowledge, enkel grote lijnen in MCQ ............................. 30
What is an ethics committee ...................................................................................................................................... 30
Why ethics committees .............................................................................................................................................. 30
Ethical review .............................................................................................................................................................. 30
Clinical ethics versus research ethics .......................................................................................................................... 30
Protection of subject................................................................................................................................................... 31
Basic texts on ethics in clinical research ..................................................................................................................... 31
Nuremberg Code ......................................................................................................................................................... 31
Wil jij €76 per
Dit document is auteursrechtelijk beschermd, het verspreiden van dit document is strafbaar. maand verdienen?
, Stuvia - Koop en Verkoop de Beste Samenvattingen
The declaration of Helsinki (2013) .............................................................................................................................. 31
Additional guidelines .................................................................................................................................................. 31
Clinical trial regulation ................................................................................................................................................ 32
Functie ethics committee: ICH guidelines................................................................................................................... 33
Written policies and procedures................................................................................................................................. 33
Participation in clinical trials ....................................................................................................................................... 34
Negative advice ........................................................................................................................................................... 34
Faq’s ............................................................................................................................................................................ 34
Financial aspects of clinical trials ................................................................................................................................ 35
Follow-up .................................................................................................................................................................... 35
Ethics of EC/IRB ........................................................................................................................................................... 35
Potential conflict of interest ....................................................................................................................................... 36
Dealing with conflicts of interest ................................................................................................................................ 36
Quality of ethical review ............................................................................................................................................. 36
Quality assurance metrics ........................................................................................................................................... 36
Quality of decision making .......................................................................................................................................... 37
Current status of CTR clinical trial regulation ............................................................................................................. 37
Low intervention clinical trial...................................................................................................................................... 37
Research challenged by GDPR?................................................................................................................................... 38
Data storage and handling .......................................................................................................................................... 38
Difficulty in identifying (secondary) research purposes in the future in advance ...................................................... 38
Conclusions ................................................................................................................................................................. 38
Les 2.1 Statistics in clinical trials: Does sample size really matter for a clinical trial? .................................................... 40
1. Circle of research ................................................................................................................................................ 40
2. What is hypothesis testing? ................................................................................................................................ 40
3. Statistical methods.............................................................................................................................................. 40
4. What is a sample size? ........................................................................................................................................ 41
5. How large should the sample be? ....................................................................................................................... 41
6. Significance level α and power (1 − β) ................................................................................................................ 41
7. Fundamental points ............................................................................................................................................ 42
8. Treatment A or B? ............................................................................................................................................... 42
9. How to get sample size – rough idea .................................................................................................................. 43
10. What is needed for sample size calculation? .................................................................................................. 43
11. Sample size calculation ................................................................................................................................... 43
12. Simple formula for difference in proportions ................................................................................................. 44
13. Exercise ........................................................................................................................................................... 44
14. Effect size ↔ sample size per group .............................................................................................................. 44
15. Some further topics ........................................................................................................................................ 45
16. Summary ......................................................................................................................................................... 45
Wil jij €76 per
Dit document is auteursrechtelijk beschermd, het verspreiden van dit document is strafbaar. maand verdienen?
, Stuvia - Koop en Verkoop de Beste Samenvattingen
Les 3: Start up and conduct of a clinical trial (open and general questions), Role, tasks, responsibilities of CRO,
CRA, monitor, sponsor, investigator.......................................................................................................................... 46
Definitions ................................................................................................................................................................... 46
Medical device development timeline........................................................................................................................ 47
Main players................................................................................................................................................................ 48
Set-up and conduct of a clinical trial:.......................................................................................................................... 49
Material requirements – sponsor and investigator .................................................................................................... 49
Clinical trials start-up and conduct ............................................................................................................................. 52
Safety reporting .......................................................................................................................................................... 56
Les 4: Study design => multiple choice questions, geen details, geen historische details, de belangrijke concepten
goed kennen ................................................................................................................................................................... 59
Introduction: towards the gold standard.................................................................................................................... 59
Historical examples ................................................................................................................................................. 59
Why clinical trials? ...................................................................................................................................................... 59
Choosing the right timing............................................................................................................................................ 59
Study protocol ............................................................................................................................................................. 59
RCT = golden standard for clinical trials = randomized controlled trials .................................................................... 60
Randomised double-blind placebo-controlled clinical trial = golden standard ..................................................... 61
Posing the right question ............................................................................................................................................ 62
Choosing the right population .................................................................................................................................... 63
Defining the treatment schedule ................................................................................................................................ 64
Special designs ............................................................................................................................................................ 65
Les 4.2 Data management (geen slides van, wel document van wat te kennen) .......................................................... 65
Les 4.3 Data analysis ....................................................................................................................................................... 68
Clinical trial Reporting ................................................................................................................................................. 68
Les 4.4 Placebo................................................................................................................................................................ 69
History ......................................................................................................................................................................... 69
Placebo-RCT-Double blind .......................................................................................................................................... 69
From decoy to powerfull to powerless ....................................................................................................................... 70
Hoe lang werkt placebo? ............................................................................................................................................ 70
What results are most important?.............................................................................................................................. 70
Natural history ............................................................................................................................................................ 71
Regression to the mean .............................................................................................................................................. 71
Conditioning ................................................................................................................................................................ 71
Hawthorne effect ........................................................................................................................................................ 71
Chirurgische placebo ................................................................................................................................................... 71
Special placebo’s ......................................................................................................................................................... 71
Nocebo in clinical trials ............................................................................................................................................... 71
Pharmacology van placebo effecten ........................................................................................................................... 72
Vooroordeel in interpretatie van klinische trials ........................................................................................................ 72
Wil jij €76 per
Dit document is auteursrechtelijk beschermd, het verspreiden van dit document is strafbaar. maand verdienen?
