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Bryan Remuto
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Decks in this class (48)
E2: CLINICAL SAFETY DATA MANAGEMENT
Adverse event or adverse experience,
Adverse drug reaction adr,
Unexpected adverse drug reaction
8
cards
E6: GUIDELINE FOR GOOD CLINICAL PRACTICE VOCABULARY
Adverse drug reaction adr,
Adverse event ae,
Applicable regulatory requirement s
62
cards
E6: 13 PRINCIPLES OF GCP
22,
21,
23
13
cards
E6: IRB/IEC - Responsibilities
Irb iec,
The irb iec should obtain the fol...,
312
9
cards
E6: IRB/IEC - Composition, Functions and Operations
321,
322,
323
6
cards
E6: IRB/IEC - Procedures
The IRB/IEC should establish, document in writing, and follow its procedures, which should include:
9
cards
E6: Investigator's Qualifications and Agreements
411,
412,
413
11
cards
E6: Medical Care of Trial Subjects
432,
431,
433
4
cards
E6: Communication with IRB/IEC
44 communication with irb iec441,
442,
443
3
cards
E6: Compliance with Protocol
45 compliance with protocol,
452,
453
4
cards
E6: Investigational Products
455,
456,
463
6
cards
E6: Informed Consent of Trial Subjects
48 informed consent of trial subj...,
482,
483
15
cards
E6: Records and Reports
49 records and reports490,
491,
492
10
cards
E6: Safety Reporting
411 safety reporting,
4112,
4113
3
cards
E6: Premature Termination or Suspension of a Trial
412 premature termination or susp...,
4121,
4122
5
cards
E6: Quality Management
50 quality management,
501,
502
8
cards
E6: Quality Assurance and Quality Control
51 quality assurance and quality ...,
512,
513
4
cards
E6: Contract Research Organization (CRO)
52 contract research organization...,
522,
523
4
cards
E6: Trial Management, Data Handling, and Record Keeping
Trial management data handling an...,
552,
553
12
cards
E6: Investigator Selection
56 investigator selection561,
562,
563
3
cards
E6: Notification/Submission to Regulatory Authority(ies)
510 before initiating the clinica...
1
cards
E6: Confirmation of Review by IRB/IEC
511 confirmation of review by irb...,
5112,
5113
3
cards
E6: Information on Investigational Product(s)
512 information on investigationa...,
5122
2
cards
E6: Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)
513 manufacturing packaging label...,
5132,
5134
5
cards
E6: Supplying and Handling Investigational Product(s)
514 supplying and handling invest...,
5142,
5143
5
cards
E6: Safety Information
516 safety information5161,
5162,
517 adverse drug reaction reporti...
5
cards
E6: Monitoring
518 monitoring5181 purpose,
5182 selection and qualifications...,
5183 extent and nature of monitoring
3
cards
E6: Monitoring Responsibilities
5184 monitor s responsibilities,
A,
B
18
cards
E6: Monitoring Report/Plan
5186 monitoring reporta,
B,
C
6
cards
E6: Audit
519 auditif or when sponsors perf...,
Purpose,
5193 auditing procedures
3
cards
E6: Noncompliance/Premature Term or Suspension of Trial
Noncompliance5201,
Noncompliance5202,
Premature termination or suspensi...
4
cards
E6: Multicentre Trials
523 multicentre trialsfor multice...,
Multicentre trials523,
Multicentre trials523
5
cards
E6: CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
Clinical trial protocol and proto...,
Clinical trial protocol and proto...,
612
30
cards
E6: Investigation Brochure
7 investigation brochuretitle page,
Contents of the investigator s br...,
Contents of the investigator s br...
8
cards
E6: Essential Documents
81,
Essential documents81,
Essential documents81
7
cards
E8: GENERAL CONSIDERATIONS FOR CLINICAL STUDIES
31 considerations for the develop...,
3111 safety studiesfor the first ...,
3112 pharmacological and pharmaco...
3
cards
1572 Form
1572
1
cards
Belmont Report
Respect for persons,
Beneficence,
Justice
3
cards
Declaration of Helsenki
Declaration of helsenki,
Declaration of helsenki,
Declaration of helsenki
37
cards
Nuremberg Code
Nuremberg code1,
Nuremberg code2,
Nuremberg code3
10
cards
Pill Calculation - Compliance
Pill count method
1
cards
E8: Phase I (Most typical kind of study: Human Pharmacology)
Phase ipharmacologyobjective of s...,
Phase ipharmacologystudy examples,
3131 phase i most typical kind of...
7
cards
E 8: Phase II (Most typical kind of study: Therapeutic Exploratory)
Phase iitherapeutic exploratory,
2
cards
E8: Phase III (Most typical kind of study: Therapeutic Confirmatory)
Phase iiitherapeuticconfirmatory,
Phase iiitherapeuticconfirmatorys...
2
cards
E8: Phase IV (Variety of Studies: - Therapeutic Use)
Phase ivtherapeutic useobjective ...,
Phase ivtherapeutic useobjective ...
2
cards
E8: General Consideration for Clinical Trials
3135,
314 special considerations,
3141 studies of drug metabolites
4
cards
E9: STATISTICAL PRINCIPLES FOR CLINICAL TRIALS
212 confirmatory trial,
Exploratory,
Human pharmacology
9
cards
E11: Clinical Trials in Pediatric Population
0
cards
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