Event Calendar

Regulatory Updates for Clinical Research Professionals - RECERTIFICATION

Updated January 2019

This Learning Module is intended to encourage the reader to maintain an understanding of current activities involved in the conduct of research involving human subjects. The module offers one SOCRA continuing education unit to those who complete the review and correctly answer ten of eleven questions.

The module is offered at no cost as a public service. The readers should complete the module at their own pace – there is no time limit.

Once the questions have been answered "off-line" please proceed to the "on-line" module to complete this process and to print your certificate of completion. You may download the PDF here

When you are prepared to access the "on-line" module, please go to https://socra.elevate.commpartners.com, to enter your contact information and to complete the "on-line" module, and to receive your certificate of completion.

Acronyms used: 

CFR

United States Code of Federal Regulations (US FDA regulations)

GCP

Good Clinical Practice

ICH

International Council on Harmonisation

IRB/IEC  

Institutional Review Board/Independent Ethics Committee

NIH

National Institutes of Health

NSR

Non-Significant Risk

We suggest you print and review the following documents and answer ALL questions "off-line."  Once the questions have been answered "off-line," please proceed to the "on-line" module to complete this process and to print your certificate of completion.  This module offers one SOCRA continuing education unit.

  1. 45 CFR 46
  2. ICH / GCP E6(R2) (International Council on Harmonization)
  3. 21 CFR 812

 

Please circle the correct answer for each question below:

 

Refer to 45 CFR 46 Subpart A of the revised Common Rule for questions 1, 2, and 3

1. Under the Revised Common Rule (2018), continuing IRB review is required for:

a. research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year

b. research eligible for expedited review

c. exempt research

d. research that has completed all interventions and now only includes accessing follow up clinical data from procedures that subjects would undergo as part of clinical care

 

2. Under the revised Common Rule (2018), what change was made to the basic elements of informed consent?

a. no changes were made to the basic elements of informed consent

b. addition of an element to provide notice whether participants’ information or biospecimens collected as part of the current research might be used for research in a different disease in the future

c. addition of an element to provide notice whether participants’ information or biospecimens collected as part of the current research might be used for research in the same disease as the patient in the future

d. addition of an element to provide notice whether participants’ information or biospecimens collected as part of the current research might be stripped of identifiers and used for other research in the future

 

3. Under the revised Common Rule (2018), which of the following would NOT be a required element for broad consent for the storage, maintenance and secondary research use of identifiable private information or identifiable biospecimens?

a. the approximate number of participants

b. a general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens

c. an explanation of whom to contact for answers to questions about the subject’s rights

d. unless the subject will be provided details about specific research studies, a statement that they will not be informed of any specific research studies that might be conducted using their identifiable private information or identifiable biospecimens

 

Please review ICH/GCP E6(R2) March 2018 Procedural to answer questions 4, 5, 6, 7, 8

4. In accordance with ICH/GCP E6 (R2) what constitutes a “certified copy” in relation to source documents?

a. a paper copy signed by the Research Coordinator certifying that the copy has the same information as the original source.

b. a paper copy signed by the Principal Investigator certifying that the copy is the same as the original source.

c. an electronic document signed electronically by the Principal Investigator indicating the record is the same as the original source.

d. a copy of the original record (irrespective of type of media used) that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information

 

5. In accordance with ICH/GCP E6 (R2) an investigator is responsible to ensure adequate resources. Which of the following is NOT part of the investigator’s responsibilities?

a. Responsibility to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period

b. Responsibility for supervising any individual to whom the investigator delegates trial-related duties and functions conducted at the trial site

c. Responsibility to ensure appropriate remuneration of trial-related staff

d. If the investigator/institution retains the services of any individual or party to perform trial-related duties and functions, the investigator/institution should ensure this individual or party is qualified to perform those trial-related duties and functions and should implement procedures to ensure the integrity of the trial-related duties and functions performed and any data generated

 

6. In accordance with ICH/GCP E6 (R2) an individual designated by the investigator/institution should maintain records of investigational product delivered to the trial site. What should these records include?

a. Dates and quantities of investigational product delivered to the site, inventory at the site, use by each trial subject, disposition of unused investigational product, batch/serial numbers, expiration dates (if applicable), unique code numbers assigned to trial subjects and to the investigational products, doses provided to trial subjects, and the investigator’s medical license number

b. Dates and quantities of investigational product delivered to the site, inventory at the site, use by each trial subject, disposition of unused investigational product, batch/serial numbers, expiration dates (if applicable), unique code numbers assigned to trial subjects and to the investigational products and doses provided to trial subjects

c. Dates and quantities of investigational product delivered to the site, inventory at the site, use by each trial subject, disposition of unused investigational product, batch/serial numbers, expiration dates (if applicable), unique code numbers assigned to trial subject, doses provided to trial subjects, and the investigator’s medical license number

d. Dates and quantities of investigational product delivered to the site, inventory at the site, use by each trial subject, unique code numbers assigned to trial subjects and to the investigational products, and the investigator’s medical license number

 

7. In accordance with ICH/GCP E6 (R2) source documents and trial records should be

a. attributable, legible, contemporaneous, original, accurate and complete

b. attributable, legible, contemporaneous, original and accurate

c. attributable, contemporaneous, original and complete

d. legible, original and accurate

 

8. In accordance with ICH/GCP E6 (R2) the sponsor should implement a system to manage quality throughout all the stages of the trial process. The quality management system should use a risk-based approach that includes all of the following:

a. Risk Identification, Risk Evaluation, Risk Control, Risk Communication, Risk Review, Risk Reporting

b. Risk Control, Risk Communication, Risk Review, Risk Reporting

c. Critical Process and Data Identification, Risk Identification, Risk Evaluation, Risk Control, Risk Communication, Risk Review, Risk Reporting

d. Critical Process and Data Identification, Risk Identification, Risk Evaluation, Risk Control, Risk Communication

 

Referring to 21 CFR 812 for questions 9 and 10.

9. According to 21 CFR 812.150 unanticipated adverse device effects must be reported by the investigator to the sponsor and reviewing IRB no later than:

a. 10 days after the investigator first learns of the effect

b. 10 working days after the investigator first learns of the effect

c. 5 days after the investigator first learns of the effect

d. 5 working days after the investigator first learns of the effect

 

10. According to 21 CFR 812.3 which of the following does NOT represent a significant risk device?

a. a device which is of substantial importance in diagnosing, curing, mitigating or treating disease

b. a device which is similar to an already approved device considered not to have significant risk

c. an implant which is designed to sustain life

d. a device which would otherwise present a potential for serious risk to health, safety or welfare of a research subject

 

Please review ICH/GCP E6(R2) March 2018 Procedural to answer question 11

11. A Phase II clinical trial of an investigational agent is discontinued early by the sponsor due to significant unexpected adverse drug reactions. The sponsor determines that it is in the best interests of the patients’ safety to stop clinical development of the drug. There will be no further development of this drug. According to ICH/GCP E6(R2), how long should the sponsor and investigator retain essential documents?

a. 2 years after formal discontinuation of clinical development of the product

b. 5 years after formal discontinuation of clinical development of the product

c. 10 years after formal discontinuation of clinical development of the product

d. According to the protocol

 

Once you are prepared to complete the module, please go here, to enter your contact information and complete the module to receive your certificate of completion.