Best Practice for … Clinical Monitoring

von: Gerald Van Roey

PharmImage GmbH, 2011

ISBN: 9783862500024

Sprache: Englisch

145 Seiten, Download: 4836 KB

Format: PDF, auch als Online-Lesen

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Best Practice for … Clinical Monitoring

	1 An Introduction to Medicine andClinical Research	12
	1.1 PRECLINICAL RESEARCH	14
	1.2 CLINICAL RESEARCH	15
	1.2.1 THE FUNDAMENTAL ELEMENTSOF A CLINICAL TRIAL	16
	1.2.2 THE DIFFERENT PARTIES INVOLVED	19
	1.2.3 PHASE I	21
	1.2.4 PHASE II	22
	1.2.5 PHASE III	23
	1.2.6 PHASE IV	23
	1.2.7 REGULATIONS GUIDING CLINICALRESEARCH	24
	1.2.7.1 History	24
	1.2.7.2 DeclaraQon of Helsinki	28
	1.2.7.3 ICH-GCP	28
	1.2.7.4 European legislaQon	30
	1.2.7.5 Food & Drug AdministraQon	31
	1.2.7.6 WHO	32
	1.2.7.7 Other regulaQons	32
	2 What Makes a GoodMonitor?	38
	2.1 CHARACTERISTICS	38
	2.2 RELATIONSHIP WITH THE INVESTIGATOR	39
	2.3 TOOLS OF A MONITOR	40
	3 Key Documents in ClinicalTrials / Documents to Know	46
	3.1 PROTOCOL	46
	3.2 INFORMED CONSENT FORM	48
	3.3 CRF	50
	3.4 INVESTIGATOR BROCHURE	52
	3.5 SOURCE DOCUMENTS	53
	4 Investigator Selection	56
	4.1 SOURCES	57
	4.2 COLD CALL	57
	4.3 CONFIDENTIALITY	58
	5 How to Prepare a Visit	62
	6 Pre-Study Visit	66
	6.1 WHAT TO CHECK	66
	6.2 HOW TO CHECK	68
	6.3 PROTOCOL READINESS	68
	6.4 WHAT TO DO AFTER A VISIT	69
	6.4.1 FOLLOW-UP LETTER	69
	6.4.2 DOCUMENTATION	69
	7 The Initiation Visit	76
	7.1 TRAINING	76
	7.2 HOW TO ...	77
	7.3 WHAT TO DO AFTER AN INITIATION VISIT	78
	7.3.1 FOLLOW-UP LETTER	78
	7.3.2 DOCUMENTATION	79
	8 Monitoring Visits	84
	8.1 SOURCE DATA VERIFICATION	85
	8.1.1 ELECTRONIC CRF	86
	8.1.2 PAPER CRF	86
	8.2 INVESTIGATIONAL MEDICINAL PRODUCT	87
	8.2.1 DEFINITIONS	87
	8.2.1.1 Inves7ga7onal medicinal product	87
	8.2.1.2 Medical device	87
	8.2.1.3 Accessory	88
	8.2.1.4 AcYve implantable medical device	88
	8.2.1.5 In vitro diagnosYc devices (IVD):	88
	8.2.2 IMPORT AND EXPORT	88
	8.2.3 IMP DISTRIBUTION	89
	8.2.4 TRACKING OF IMP: SHIPMENTS	90
	8.2.5 RETURN OF USED/UNUSED IMP	91
	8.2.6 TRANSFER	91
	8.2.7 CERTIFICATE OF ANALYSIS	91
	8.2.8 INVESTIGATIONAL PRODUCT	91
	8.2.9 LABELING	92
	8.2.10 SITE INVENTORY &PATIENT ACCOUNTABILITY FORM	92
	8.2.11 STORAGE CONDITIONS	93
	8.2.12 IMP DESTRUCTION	94
	8.3 FILING	94
	8.4 SITE MANAGEMENT	95
	8.5 RECRUITMENT ISSUES	96
	8.5.1 THE RIGHT PROTOCOL	96
	8.5.2 SELECTION AND SUPPORT OF STUDY SITES	96
	8.5.3 HOW TO HELP SITES?	99
	8.5.4 KEEPING TRACK	100
	8.6 SAFETY	102
	8.6.1 ADVERSE EVENT (AE)	102
	8.6.2 ADVERSE DRUG REACTION (ADR)	104
	8.6.3 SERIOUS ADVERSE EVENT (SAE)	105
	8.6.4 SUSPECTED UNEXPECTED SERIOUSADVERSE REACTION (SUSAR)	106
	8.6.5 NOTIFICATION TO EC AND THEAUTHORITIES (EUROPEAN LEGISLATION)	107
	8.7 REPORTING BY THE MONITORS	108
	8.8 WHAT TO DO AFTER A MONITORING VISIT	109
	8.8.1 FOLLOW-UP LETTER	109
	9 The Close-Out Visit	114
	9.1 WHAT TO DO AFTER A CLOSE-OUT VISIT	115
	9.1.1 FOLLOW-UP LETTER	115
	9.1.2 DOCUMENTATION	117
	10 Audits & Inspections	120
	10.1 HOW TO PREPARE	121
	10.2 DURING AN AUDIT OR INSPECTION	121
	10.3 AFTER AN AUDIT	123
	11 Reporting & Archiving	128
	11.1 COMMUNICATION REPORTS	128
	11.1.1 EXTERNAL	128
	11.1.2 INTERNAL	129
	11.2 SAFETY REPORTING	129
	11.2.1 CIOMS REPORTS	129
	11.2.2 LINE LISTINGS	129
	11.2.3 ANNUAL SAFETY REPORT	130
	11.2.4 CLINICAL STUDY REPORT	130
	11.3 GOOD DOCUMENTATION	132
	11.4 ARCHIVING	133
	Appendix1 Answers to Self Study	136
	Appendix2 List of Abbreviaions	140
	Appendix3 Index	144

Best Practice for … Clinical Monitoring

von: Gerald Van Roey

Best Practice for … Clinical Monitoring

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