This class was created by Brainscape user Bryan Remuto. Visit their profile to learn more about the creator.
By:
Bryan Remuto
- decks
- flashcards
- learners
Decks in this class (48)
E2: CLINICAL SAFETY DATA MANAGEMENT
Adverse event or adverse experien...,
Adverse drug reaction adr 2,
Unexpected adverse drug reaction 3
8
cards
E6: GUIDELINE FOR GOOD CLINICAL PRACTICE VOCABULARY
Adverse drug reaction adr 1,
Adverse event ae 2,
Applicable regulatory requirement...
62
cards
E6: 13 PRINCIPLES OF GCP
13 principles of gcp 21 1,
13 principles of gcp 22 2,
13 principles of gcp 23 3
13
cards
E6: IRB/IEC - Responsibilities
Irb iec responsibilities 1,
Irb iec responsibilities 2,
Irb iec responsibilities 3
9
cards
E6: IRB/IEC - Composition, Functions and Operations
Irb iec composition functions and...,
Irb iec composition functions and...,
Irb iec composition functions and...
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
Investigator s qualifications and...,
Investigator s qualifications and...,
Investigator s qualifications and...
11
cards
E6: Medical Care of Trial Subjects
Medical care of trial subjects 1,
Medical care of trial subjects 1,
Medical care of trial subjects 2
4
cards
E6: Communication with IRB/IEC
44 communication with irb iec 1,
Communication with irb iec 2,
Communication with irb iec 3
3
cards
E6: Compliance with Protocol
45 compliance with protocol 1,
Compliance with protocol 2,
Compliance with protocol 3
4
cards
E6: Investigational Products
46 investigational products 1,
Investigational products 2,
Investigational products 3
6
cards
E6: Informed Consent of Trial Subjects
48 informed consent of trial subj...,
Informed consent of trial subjects 2,
Informed consent of trial subjects 3
15
cards
E6: Records and Reports
49 records and reports 1,
Records and reports 491 2,
Records and reports 492 3
10
cards
E6: Safety Reporting
411 safety reporting 1,
Safety reporting 4112 2,
Safety reporting 4113 3
3
cards
E6: Premature Termination or Suspension of a Trial
412 premature termination or susp...,
Premature termination or suspensi...,
Premature termination or suspensi...
5
cards
E6: Quality Management
50 quality management 1,
Quality management 501 critical p...,
Quality management 502 risk ident...
8
cards
E6: Quality Assurance and Quality Control
51 quality assurance and quality ...,
Quality assurance and quality con...,
Quality assurance and quality con...
4
cards
E6: Contract Research Organization (CRO)
52 contract research organization...,
Contract research organization cro 2,
Contract research organization cro 3
4
cards
E6: Trial Management, Data Handling, and Record Keeping
Trial management data handling an...,
Trial management data handling an...,
Trial management data handling an...
12
cards
E6: Investigator Selection
56 investigator selection 1,
Investigator selection 2,
Investigator selection 3
3
cards
E6: Notification/Submission to Regulatory Authority(ies)
510 notification submission to re...
1
cards
E6: Confirmation of Review by IRB/IEC
Confirmation of review by irb iec 1,
Confirmation of review by irb iec 2,
Confirmation of review by irb iec 3
3
cards
E6: Information on Investigational Product(s)
512 information on investigationa...,
Information on investigational pr...
2
cards
E6: Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)
513 manufacturing packaging label...,
Manufacturing packaging labelling...,
Manufacturing packaging labelling...
5
cards
E6: Supplying and Handling Investigational Product(s)
514 supplying and handling invest...,
Supplying and handling investigat...,
Supplying and handling investigat...
5
cards
E6: Safety Information
516 safety information 1,
Safety information 5162 2,
517 adverse drug reaction reporti...
5
cards
E6: Monitoring
518 monitoring 5181 purpose 1,
5182 selection and qualifications...,
5183 extent and nature of monitor...
3
cards
E6: Monitoring Responsibilities
5184 monitor s responsibilities 1,
Monitor s responsibilities 2,
Monitor s responsibilities 3
18
cards
E6: Monitoring Report/Plan
5186 monitoring report 1,
Monitoring report b 2,
Monitoring report c 3
6
cards
E6: Audit
519 audit if or when sponsors per...,
Audit 5192 selection and qualific...,
Audit 5193 auditing procedures 3
3
cards
E6: Noncompliance/Premature Term or Suspension of Trial
Noncompliance 5201 1,
Noncompliance 5202 2,
Premature termination or suspensi...
4
cards
E6: Multicentre Trials
Multicentre trials for multicentr...,
Multicentre trials 523 2,
Multicentre trials 523 3
5
cards
E6: CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
Clinical trial protocol and proto...,
Clinical trial protocol and proto...,
General information 612 3
30
cards
E6: Investigation Brochure
7 investigation brochure 1,
Contents of the investigator s br...,
Contents of the investigator s br...
8
cards
E6: Essential Documents
Essential documents 81 a 1,
Essential documents 81 b 2,
Essential documents 81 c 3
7
cards
1572 Form
1572 1
1
cards
Belmont Report
Belmont report respect for persons 1,
Belmont report beneficence 2,
Belmont report respect for persons 3
3
cards
E8: GENERAL CONSIDERATIONS FOR CLINICAL STUDIES
31 considerations for the develop...,
31 considerations for the develop...,
31 considerations for the develop...
3
cards
E8: Phase I (Most typical kind of study: Human Pharmacology)
Phase i pharmacology objective of...,
Phase i pharmacology study exampl...,
3131 phase i most typical kind of...
7
cards
E 8: Phase II (Most typical kind of study: Therapeutic Exploratory)
Phase ii therapeutic exploratory 1,
Blank 2
2
cards
E8: Phase III (Most typical kind of study: Therapeutic Confirmatory)
Phase iii therapeutic confirmator...,
Phase iii therapeutic confirmator...
2
cards
E8: Phase IV (Variety of Studies: - Therapeutic Use)
Phase iv therapeutic use objectiv...,
Phase iv therapeutic use study ex...
2
cards
E8: General Consideration for Clinical Trials
3135 development of an applicatio...,
314 special considerations 2,
3141 studies of drug metabolites 3
4
cards
E9: STATISTICAL PRINCIPLES FOR CLINICAL TRIALS
Confirmatory trial 1,
Exploratory 2,
Human pharmacology 3
9
cards
E11: Clinical Trials in Pediatric Population
0
cards
Pill Calculation - Compliance
Pill count method 1
1
cards
Nuremberg Code
Nuremberg code 1 1,
Nuremberg code 2 2,
Nuremberg code 3 3
10
cards
Declaration of Helsenki
Declaration of helsenki 1,
Declaration of helsenki 1,
Declaration of helsenki 2
37
cards
More about
XyZ_Res
- Class purpose General learning
Learn faster with Brainscape on your web, iPhone, or Android device. Study Bryan Remuto's XyZ_Res flashcards now!
How studying works.
Brainscape's adaptive web mobile flashcards system will drill you on your weaknesses, using a pattern guaranteed to help you learn more in less time.
Add your own flashcards.
Either request "Edit" access from the author, or make a copy of the class to edit as your own. And you can always create a totally new class of your own too!
What's Brainscape anyway?
Brainscape is a digital flashcards platform where you can find, create, share, and study any subject on the planet.
We use an adaptive study algorithm that is proven to help you learn faster and remember longer....
Looking for something else?
Research
- 28 decks
- 474 flashcards
- 36 learners
Decks:
Ch1research, Ch2research, Ch3research, And more!
Research
- 20 decks
- 523 flashcards
- 263 learners
Decks:
Chapter 9 Quantitative Research Basics, Chapter 20 Qualitative Research Basics, Ch 27 5 Librarian Powerpoint Literature, And more!
Practical Research II
- 23 decks
- 465 flashcards
- 30 learners
Decks:
Q1 Introduction To Quantitative Research, Q1 Importance Of Quantitative Research A, Q1 Variables, And more!
Research Methods
- 34 decks
- 550 flashcards
- 130 learners
Decks:
General, Control Of Variables, Experimental Design, And more!
