SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
6.1 General Information - -Protocol title, protocol identifying number and date. Any amendments should
bear the amendment numbers and dates -name and address of sponsor and monitor
-name and titlke of persons authorized to sign than the sponsor
-name and title, adddress and telephone numebrs of the sponsors medical expert for the trial
-name ad title of the investigators who are responsible for conducting the tiral and the address and
telephone numbers of the tiral sites
-name, title and address and telephone numebrs of the physician responsible for all trila site realsped
medical decisions
-names and addresses of clinical labratory and any other medical or technical department or institutions
involved in the trial
6.11-6.13 - -6.11 Quality control and assurance
-6.12 Ethics: description of ethical considerations relating to the trial
-6.13 Data handling and recordkeeping
6.14-6.16 - -6.14 Financing and insurance: financing and insurance if not addressed in a separate
agreement
-6.15 Publication policy: publication policy, if not addressed in sperate document
6.16 Supplements
* Since the protocol and clinical trial/study report are closely related, further relevant information can
be found in the ICH guidance for structure and content of clinical study reports
6.2 Background Information - -name and description of the investigational product
-a summary of the findings from nonclinical studies that potentially have clinical significance and from
clinical trials that are relevant to the trial
--summary of the known and potential risks and benefits to human subjects
-description of and justification for the route of administration, dosage, dosage regimen, and treatment
periods
-a statement the trial will be conducted in compliance with the protocol, GCP and the applicable
regulatory requirements
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
,SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
-Description of the population to be studied
-references to literature and data that are relevant to the trial, and that provide background for the trial
6.3 Trial Objectives and Purpose - A detailed description of the objectives and the purpose of the trial
6.4 Trial Design - -A specific statements of the primary endpoints and the secondary endpoints, if any to
be measured during the trial
-a description of the type/design of the trial to be conducted (ex: double blinded, placebo control) and a
schematic diagram of the trial design , procedures and stages
-a description of the measures, taken to minimize/avoid bias, including for examples randomization and
blinding
-a description of the trial treatments, the dosages, dosage regimen, dosage forms, packaging, and
labeling of the investigational product
-the expected duration of the subject participation and a description of the sequence and duration of all
trial periods, including follow-up if any
-a description of the stopping rules and discontinuation criteria for individual subjects, parts of trial and
entire trial
-accountability procedures for the products, including placebo and comparators, if any
-maintenance of trial treatment randomization codes and procedures for creaking codes
-the identification of any data to be recorded directly to the CRF's (ex: no prior written electronic record
of data) and to be considered to be source data.
6.5 Selection and Withdrawal of Subjects - -subject inclusion criteria
-subject exclusion criteria
-subject withdrawal criteria and procedures specifying: -when and how to withdraw subjects from the
trial/investigation product treatmetn
-the type and timinig of the data to be collected for withdrawn subjects
-whether and how subjects are to be replaces
-The follow-up for subjects withdrawn from investigational product treatment/trial treatment
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
, SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
6.6 Treatment of subjects - -The treatments to be administered, including the names of all the products,
the doses, the dosing schedule, the route administration, and the treatment periods, including the
follow-up periods for subjects for each investigational product treatment/trial treatment group.am of
trial
-medications , treatments permitted (including rescue meds) and not permitted before or during the
trial
-procedures for monitoring subject compliance
6.7 Assessment of Efficacy - -specification of the efficacy parameters
-methods of timing and assessing, recording, and analyzing the efficacy parameters
6.8 Assessment of safety - -specification of safety parameters
-the methods and timing for assessing, recording and analyzing safety parameters
-procedures for eliciting reports of and for recording and reporting adverse event and intercurrent
illnesses
-the type and duration of follow-up for subjects after adverse events
6.9 Statistics - -a description of the statistical methods to be employed, including timing of any planned
interim analysis
-the number of subjects planned to be enrolled. In multicenter trials, the number of enrolled subjects
protected for each trial sites should be specified. reason for choice of sample size, including reflections
on the power of the trial and clinician justification
-the level of significance to be used
-criteria for the termination for the trial
-procedure for accounting for missing, unused, and spurious data
-procedures for reporting aby deviations from the original statistical plan (any deviations from the
original statistical plan should be described and justified in the protocol and or in the final report as
appropriate).
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
CORRECT ANSWERS 2025
6.1 General Information - -Protocol title, protocol identifying number and date. Any amendments should
bear the amendment numbers and dates -name and address of sponsor and monitor
-name and titlke of persons authorized to sign than the sponsor
-name and title, adddress and telephone numebrs of the sponsors medical expert for the trial
-name ad title of the investigators who are responsible for conducting the tiral and the address and
telephone numbers of the tiral sites
-name, title and address and telephone numebrs of the physician responsible for all trila site realsped
medical decisions
-names and addresses of clinical labratory and any other medical or technical department or institutions
involved in the trial
6.11-6.13 - -6.11 Quality control and assurance
-6.12 Ethics: description of ethical considerations relating to the trial
-6.13 Data handling and recordkeeping
6.14-6.16 - -6.14 Financing and insurance: financing and insurance if not addressed in a separate
agreement
-6.15 Publication policy: publication policy, if not addressed in sperate document
6.16 Supplements
* Since the protocol and clinical trial/study report are closely related, further relevant information can
be found in the ICH guidance for structure and content of clinical study reports
6.2 Background Information - -name and description of the investigational product
-a summary of the findings from nonclinical studies that potentially have clinical significance and from
clinical trials that are relevant to the trial
--summary of the known and potential risks and benefits to human subjects
-description of and justification for the route of administration, dosage, dosage regimen, and treatment
periods
-a statement the trial will be conducted in compliance with the protocol, GCP and the applicable
regulatory requirements
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
,SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
-Description of the population to be studied
-references to literature and data that are relevant to the trial, and that provide background for the trial
6.3 Trial Objectives and Purpose - A detailed description of the objectives and the purpose of the trial
6.4 Trial Design - -A specific statements of the primary endpoints and the secondary endpoints, if any to
be measured during the trial
-a description of the type/design of the trial to be conducted (ex: double blinded, placebo control) and a
schematic diagram of the trial design , procedures and stages
-a description of the measures, taken to minimize/avoid bias, including for examples randomization and
blinding
-a description of the trial treatments, the dosages, dosage regimen, dosage forms, packaging, and
labeling of the investigational product
-the expected duration of the subject participation and a description of the sequence and duration of all
trial periods, including follow-up if any
-a description of the stopping rules and discontinuation criteria for individual subjects, parts of trial and
entire trial
-accountability procedures for the products, including placebo and comparators, if any
-maintenance of trial treatment randomization codes and procedures for creaking codes
-the identification of any data to be recorded directly to the CRF's (ex: no prior written electronic record
of data) and to be considered to be source data.
6.5 Selection and Withdrawal of Subjects - -subject inclusion criteria
-subject exclusion criteria
-subject withdrawal criteria and procedures specifying: -when and how to withdraw subjects from the
trial/investigation product treatmetn
-the type and timinig of the data to be collected for withdrawn subjects
-whether and how subjects are to be replaces
-The follow-up for subjects withdrawn from investigational product treatment/trial treatment
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
, SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
6.6 Treatment of subjects - -The treatments to be administered, including the names of all the products,
the doses, the dosing schedule, the route administration, and the treatment periods, including the
follow-up periods for subjects for each investigational product treatment/trial treatment group.am of
trial
-medications , treatments permitted (including rescue meds) and not permitted before or during the
trial
-procedures for monitoring subject compliance
6.7 Assessment of Efficacy - -specification of the efficacy parameters
-methods of timing and assessing, recording, and analyzing the efficacy parameters
6.8 Assessment of safety - -specification of safety parameters
-the methods and timing for assessing, recording and analyzing safety parameters
-procedures for eliciting reports of and for recording and reporting adverse event and intercurrent
illnesses
-the type and duration of follow-up for subjects after adverse events
6.9 Statistics - -a description of the statistical methods to be employed, including timing of any planned
interim analysis
-the number of subjects planned to be enrolled. In multicenter trials, the number of enrolled subjects
protected for each trial sites should be specified. reason for choice of sample size, including reflections
on the power of the trial and clinician justification
-the level of significance to be used
-criteria for the termination for the trial
-procedure for accounting for missing, unused, and spurious data
-procedures for reporting aby deviations from the original statistical plan (any deviations from the
original statistical plan should be described and justified in the protocol and or in the final report as
appropriate).
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
