Free Preparation Discussions
MENU
SOCRA CCRP Exam Questions
- Topic 1: Research Study Start-Up: This section of the exam measures the skills of Clinical Research Coordinators and covers the initial planning and setup of a clinical trial. It involves coordinating the development of the study protocol, ensuring it considers ethical guidelines and regulatory pathways like IND or IDE. It also includes creating essential study documents like informed consent forms and case report forms. The domain covers obtaining necessary approvals from stakeholders like the IRB and sponsor, selecting study sites, training staff, and ensuring the study's compliance with various laws. Additionally, it involves obtaining the research product and preparing all necessary tools and documentation for the study's commencement.
- Topic 2: Research Study Implementation: This section of the exam measures the skills of Clinical Research Associates and covers the active management and execution of the clinical trial. It focuses on following the study protocol and standard operating procedures, managing the investigational product, and ensuring ongoing regulatory compliance. The domain includes identifying, documenting, and reporting any study anomalies such as adverse events or protocol deviations. It also involves managing subject recruitment, consent, and retention, as well as maintaining all study records and essential documents. Furthermore, it covers communicating with all study stakeholders and participating in study audits to ensure quality and adherence to regulations.
- Topic 3: Research Study Closure: This section of the exam measures the skills of Clinical Research Coordinators and covers the activities required to properly conclude a clinical trial. It involves participating in the study closeout visit to verify documentation and account for the investigational product. The domain also includes developing and submitting final closure reports to the IRB, study sponsor, regulatory authorities, and clinicaltrials.gov. Finally, it covers the procedures for archiving study records.
Free SOCRA CCRP Exam Actual Questions
Note: Premium Questions for CCRP were last updated On Oct. 16, 2026 (see below)
In accordance with the ICH E2A Guideline, the sponsor must report an adverse event that is life-threatening, unexpected, and associated with the investigational drug to the regulatory authority as soon as possible but no later than how many calendar days after first knowledge of the event?
Serious adverse events are subject to expedited reporting requirements.
ICH E2A 3.2.2: ''Fatal or life-threatening unexpected ADRs should be reported as soon as possible but no later than 7 calendar days after first knowledge.''
ICH E2A 3.2.3: Other serious unexpected events must be reported within 15 days.
Thus, the 7-day rule applies to life-threatening and unexpected events (as in this case).
Correct answer: B (7 days).
ICH E2A, 3.2.2.
For an investigational new drug study that has potential side effects of myalgia, arthralgia, and lethargy, which of the following could serve as an acceptable consent statement?
Consent forms must present information in language understandable to the subject, avoiding technical jargon.
21 CFR 50.20: ''The information... shall be understandable to the subject... and not include any exculpatory language.''
ICH E6(R2) 4.8.6: Information should be presented in language non-technical and understandable to the subject.
Thus, while medical terms (myalgia, arthralgia) are precise, they may not be understandable to laypersons. The correct format uses layman's terms: ''muscle aches, joint pain, and tiredness'' (B).
Correct answer: B.
21 CFR 50.20.
ICH E6(R2), 4.8.6.
After randomization, investigational drug is shipped to site. Who is responsible for accountability?
ICH E6(R2) 4.6.1: ''Responsibility for investigational product accountability at the trial site rests with the investigator.''
May delegate to pharmacist or coordinator, but ultimate responsibility lies with investigator.
Which countries have officially adopted ICH-GCP E6(R2) as a standard, in addition to U.S., EU, Japan, Canada, and Australia?
India has aligned national regulations with ICH-GCP.
DCGI/ICMR Guidelines (India): Explicitly adopt ICH E6(R2) as part of its Good Clinical Practice standards.
China and Brazil are harmonizing, but full official adoption is noted in India.
A revised protocol added genomic testing to banked tissue samples. Before shipping samples, what must the site do?
21 CFR 56.109(a): IRB must review and approve any protocol amendments before implementation.
ICH E6(R2) 4.5.2: Changes affecting subjects (e.g., genomic testing) require IRB/IEC approval and updated consent.
Thus, site must first obtain IRB approval for revised protocol and ICF.
- Select Question Types you want
- Set your Desired Pass Percentage
- Allocate Time (Hours : Minutes)
- Create Multiple Practice tests with Limited Questions
- Customer Support
Nathan Flores
1 month agoJoshua White
2 months agoEdward Thompson
2 months agoPatricia Bailey
3 months agoJoshua Perez
3 months agoDennis Young
4 months agoNathan Nelson
4 months agoOlivia Morris
5 months agoDaniel Rivera
5 months agoJustin Garcia
6 months agoJennifer Mitchell
6 months agoTiffany Davis
6 months agoFrank Edwards
6 months agoBarbara Turner
6 months agoJustin Turner
5 months agoDonald Rogers
5 months agoLoren
7 months agoBelen
7 months agoTerrilyn
7 months agoLeila
7 months agoCarol
8 months agoMadelyn
8 months agoDong
8 months agoShannan
8 months agoLatrice
9 months agoLai
9 months agoJackie
9 months agoDaren
9 months agoIzetta
10 months agoFrancesco
10 months agoGlynda
10 months agoArminda
10 months agoRory
11 months agoHyun
11 months agoTasia
11 months agoTaryn
11 months agoShelba
12 months agoLuann
12 months agoLai
1 year agoDorsey
1 year agoAnisha
1 year agoIluminada
1 year ago