ACRP-CP Final Exam With Complete
questions and correct verified answers
(detailed answers) already graded A+
Required Information in a Protocol, Continued - {✔✔RESOLUTION RESULT VERIFIED
ANSWERS✔✔}-Selection and Withdrawal of Subjects:
- Inclusion/exclusion criteria
- Withdrawal criteria (when and how to withdraw from IP, the type and timing of data to be
collected from withdrawn subjects, whether and how subjects are to be replaced, the follow-
up for subjects who have been withdrawn from IP)
Treatment of Subjects:
- The treatment to be administered and how (route, duration, dose, etc)
- Medications and treatments permitted and not permitted
,- Procedures for monitoring compliance
Assessment of Efficacy:
- Specification of the efficacy parameter
- Methods and timing for assessing efficacy parameters
Assessment of Safety:
- Specification of safety parameters
- Methods and timing for assessing safety parameters
- Procedures for eliciting reports and recording AE/intercurrent illnesses
- Type/duration of follow-up after AEs
Statistics:
- Description of the statistical methods to be employed/timing of interim analyses
- The number of subjects planned to be enrolled.
- Level of significance to be used.
- Criteria for termination of the trial.
- Procedure for accounting for missing, unused, and spurious data. - Procedures for reporting
any deviations from the original statistical plan
- The selection of subjects to be included in the statistical analysis.
Direct Access to Source Data/Documents:
- Investigator will permit monitoring, audits, IRB/IEC review and regulatory inspections.
Quality Control/Assurance
Ethics
, Data Handling and Record Keeping
Financing and Insurance
Publication Policy
Supplements
How often should an IB be reviewed? - {✔✔RESOLUTION RESULT VERIFIED
ANSWERS✔✔}-At least annually
The IB should include: - {✔✔RESOLUTION RESULT VERIFIED ANSWERS✔✔}-General:
- Title page (sponsor's name, IP name, release date, edition number, reference to number and
date of the edition it supersedes)
- Confidentiality Statement (asking investigators to treat the IB as a confidential document)
Contents:
- Table of Contents
- Summary
- Introduction (chemical name, all active ingredients, pharmacologic class, rationale for
performing the research, anticipated indication, general approach to be followed in evaluating
the IP)
- Physical, chemical and Pharmaceutical Properties and Formulation (exipients, instructions for
the storage and handling, structural similarities to known compounds)
- Nonclinical Studies (methodology, results and discussion of relevance of any nonclinical
studies that looked at the pharmacology, toxicology, pharmacokinetic and metabolism)
- Effects in Humans (Pharmacokinetics and metabolism, safety and efficacy, marketing
experience)
questions and correct verified answers
(detailed answers) already graded A+
Required Information in a Protocol, Continued - {✔✔RESOLUTION RESULT VERIFIED
ANSWERS✔✔}-Selection and Withdrawal of Subjects:
- Inclusion/exclusion criteria
- Withdrawal criteria (when and how to withdraw from IP, the type and timing of data to be
collected from withdrawn subjects, whether and how subjects are to be replaced, the follow-
up for subjects who have been withdrawn from IP)
Treatment of Subjects:
- The treatment to be administered and how (route, duration, dose, etc)
- Medications and treatments permitted and not permitted
,- Procedures for monitoring compliance
Assessment of Efficacy:
- Specification of the efficacy parameter
- Methods and timing for assessing efficacy parameters
Assessment of Safety:
- Specification of safety parameters
- Methods and timing for assessing safety parameters
- Procedures for eliciting reports and recording AE/intercurrent illnesses
- Type/duration of follow-up after AEs
Statistics:
- Description of the statistical methods to be employed/timing of interim analyses
- The number of subjects planned to be enrolled.
- Level of significance to be used.
- Criteria for termination of the trial.
- Procedure for accounting for missing, unused, and spurious data. - Procedures for reporting
any deviations from the original statistical plan
- The selection of subjects to be included in the statistical analysis.
Direct Access to Source Data/Documents:
- Investigator will permit monitoring, audits, IRB/IEC review and regulatory inspections.
Quality Control/Assurance
Ethics
, Data Handling and Record Keeping
Financing and Insurance
Publication Policy
Supplements
How often should an IB be reviewed? - {✔✔RESOLUTION RESULT VERIFIED
ANSWERS✔✔}-At least annually
The IB should include: - {✔✔RESOLUTION RESULT VERIFIED ANSWERS✔✔}-General:
- Title page (sponsor's name, IP name, release date, edition number, reference to number and
date of the edition it supersedes)
- Confidentiality Statement (asking investigators to treat the IB as a confidential document)
Contents:
- Table of Contents
- Summary
- Introduction (chemical name, all active ingredients, pharmacologic class, rationale for
performing the research, anticipated indication, general approach to be followed in evaluating
the IP)
- Physical, chemical and Pharmaceutical Properties and Formulation (exipients, instructions for
the storage and handling, structural similarities to known compounds)
- Nonclinical Studies (methodology, results and discussion of relevance of any nonclinical
studies that looked at the pharmacology, toxicology, pharmacokinetic and metabolism)
- Effects in Humans (Pharmacokinetics and metabolism, safety and efficacy, marketing
experience)
