CCRC EXAM SOLVED 100% CORRECT!!
Protocols
1) General Information
2) Background info
3) Trial objectives and purpose
4) Trial design
5) Selection and withdrawal of subjects
6) Treatment of Subjects
7) Assessment of Efficacy
8) Assessment of Safety
9) Statistics
10) Source Data/Docs
11) Quality control/assurance
12) ethics
13) data handling and record keeping
14) financing and insurance
15) publication policy
16) supplements
Phase 1
-intro of new drug/investigational product into humans
-healthy population (exception: oncology and HIV)
-design: single dose, open label, max tolerated dose
-PR, PD, BA, BE, dosing, metabolis
*focus is SAFETY
Phase 2
-Intro to subjects with disease
-design: compare with placebo (exception: cancer and antibiotics), double blind
*AIM: define dose
evaluate short term safety and efficacy in patients with disease
dose response, dose tolerance, AE's
Phase 3
-Evaluate overall benefit to risk in large group of patients
-broader eligibility, 2 or 3 tx groups. controlled or uncontrolled
*AIM: establish long-term safety and efficacy with selected doses in broad subject
sample
dosing invervals, drug-drug interactions, risk-benefit
pivotal to FDA approval
Phase 4 - Post Marketing
Continue to collect long-term safety data and gather optimal use info
Conduct AFTER regulatory approves IND
Open label
IND - Investigational New Drug
Application - FDA form 1571
Permit to perform research with a specific investigational new drug on humans for the
, first time in the US
Includes: background info, rationale, sponsors plan
Continually amended by sponsors to reflect protocol changes and new info
Effective 30 days after receipt by FDA
Updated annually by sponsors
Documents/Filing Investigator Only
1)Advertisement for subject recruitment
2) signed inform consent
3) source docs
4) subject enrollment logs
5) final report by investigator to IRB
6) completed subject ID code list
Documents/Filing Sponsor Only
1) sample of label attached to IP container
2) certificate of analysis of IP product shipped
3) master randomization list
4) pre-trial monitoring report
5) certificate of analysis for new batched of IP
6) monitoring visit reports
7) audit certificate
8) final trial close-out monitoring report
9) treatment allocation and decoding docs
All other forms are in BOTH sponsor and investigator files
Form 1572 - Statement of Investigator
Need to complete if sponsor is intending to file for marketing approval of an IP in the US
Commitment to:
1) conduct investigation with protocol, FDA regs and IRB conditions
2) make changes only with appropriate sponsor and IRB approval
3) Ensure informed consent requirements are met
4) report AE's
5) keep current records
6) personally conductors supervise investigation
7) read and understand investigator brochure
8) ensure IRB reviews and approves the study initially and on a continuing basis
Forms: FDA
1571: IND application
1572: Statement of Investigator
482: Notice of inspection
483: inspectional observations
3454: certification-financial interests of clinical investigators
3455: disclosure-financial interests of clinical investigators
3500: voluntary reporting of AE's and product problems
3500A: for use by user-facilities distributors, manufacturers for mandatory reporting
Investigators Brochure
compiles the clinical and nonclinical data on product relevant to study.
may be official labeling for pdt.
Protocols
1) General Information
2) Background info
3) Trial objectives and purpose
4) Trial design
5) Selection and withdrawal of subjects
6) Treatment of Subjects
7) Assessment of Efficacy
8) Assessment of Safety
9) Statistics
10) Source Data/Docs
11) Quality control/assurance
12) ethics
13) data handling and record keeping
14) financing and insurance
15) publication policy
16) supplements
Phase 1
-intro of new drug/investigational product into humans
-healthy population (exception: oncology and HIV)
-design: single dose, open label, max tolerated dose
-PR, PD, BA, BE, dosing, metabolis
*focus is SAFETY
Phase 2
-Intro to subjects with disease
-design: compare with placebo (exception: cancer and antibiotics), double blind
*AIM: define dose
evaluate short term safety and efficacy in patients with disease
dose response, dose tolerance, AE's
Phase 3
-Evaluate overall benefit to risk in large group of patients
-broader eligibility, 2 or 3 tx groups. controlled or uncontrolled
*AIM: establish long-term safety and efficacy with selected doses in broad subject
sample
dosing invervals, drug-drug interactions, risk-benefit
pivotal to FDA approval
Phase 4 - Post Marketing
Continue to collect long-term safety data and gather optimal use info
Conduct AFTER regulatory approves IND
Open label
IND - Investigational New Drug
Application - FDA form 1571
Permit to perform research with a specific investigational new drug on humans for the
, first time in the US
Includes: background info, rationale, sponsors plan
Continually amended by sponsors to reflect protocol changes and new info
Effective 30 days after receipt by FDA
Updated annually by sponsors
Documents/Filing Investigator Only
1)Advertisement for subject recruitment
2) signed inform consent
3) source docs
4) subject enrollment logs
5) final report by investigator to IRB
6) completed subject ID code list
Documents/Filing Sponsor Only
1) sample of label attached to IP container
2) certificate of analysis of IP product shipped
3) master randomization list
4) pre-trial monitoring report
5) certificate of analysis for new batched of IP
6) monitoring visit reports
7) audit certificate
8) final trial close-out monitoring report
9) treatment allocation and decoding docs
All other forms are in BOTH sponsor and investigator files
Form 1572 - Statement of Investigator
Need to complete if sponsor is intending to file for marketing approval of an IP in the US
Commitment to:
1) conduct investigation with protocol, FDA regs and IRB conditions
2) make changes only with appropriate sponsor and IRB approval
3) Ensure informed consent requirements are met
4) report AE's
5) keep current records
6) personally conductors supervise investigation
7) read and understand investigator brochure
8) ensure IRB reviews and approves the study initially and on a continuing basis
Forms: FDA
1571: IND application
1572: Statement of Investigator
482: Notice of inspection
483: inspectional observations
3454: certification-financial interests of clinical investigators
3455: disclosure-financial interests of clinical investigators
3500: voluntary reporting of AE's and product problems
3500A: for use by user-facilities distributors, manufacturers for mandatory reporting
Investigators Brochure
compiles the clinical and nonclinical data on product relevant to study.
may be official labeling for pdt.
