Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

SOCRA Certification > 21 Code of Federal Regulations > Flashcards

21 Code of Federal Regulations Flashcards

1
Q

What is CFR 21 Part 11?

A

This code of federal regulations pertains to Electronic Records and electronic Signatures.
(Applies to Records in electronic form not paper records sent electronically)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What is a closed system?

A

A system that is controlled by the people responsible for the EMR content.
1.Must have procedure to protect data integrity and confidentiality.
2. Must be able to create copies of records
3. Validation of systems to ensure accuracy of content
4. Protect and limit system access (Time stamps, Audit trails, and use of QA procedures)
5. Provide proper training for specific roles
6. Authority controls (Username and password)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What is an open system?

A

A system that is not controlled by the people responsible for the EMR content.
1.Must have procedure to protect data integrity and confidentiality.
2. Must be able to create copies of records
3. Validation of systems to ensure accuracy of content
4. Protect and limit system access (Time stamps, Audit trails, and use of QA procedures)
5. Provide proper training for specific roles
6. Authority controls (Username and password)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

What are the requirements for an Electronic Signature?

A
  1. Printed name
  2. Date and time of signature
  3. Reason for signature (Review, Approval, Authorization)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What is an Electronic signature?

A

After confirming the identity of an individual it is linked to them and it is only used by the individual.
Should not be re-used or re assigned to anyone else.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What is CFR 21 Part 50?

A

Protection of Human Subjects

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What must you obtain in order to involve a Human in research?

A

Informed Consent

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What is CFR 21 Part 50 Subpart B?

A

Informed Consent of Humans

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

An Informed Consent Form should not have?

A
  1. No coercion
  2. No exculpatory language
  3. No excusing an institution from liability for negligence
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What are the exceptions to obtaining an ICF?

A
  1. Emergencies ( There is no ample time to obtain, no better option for the pt.)
  2. President of USA can waive consent of IND for members of the armed forces
  3. Must have reasonable risks and prior animal/preclinical studies that display a benefit in use of IND/Device
  4. Must be able to provide the subject or LAR with ICF ASAP
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What is a LAR?

A

Legally Appointed Representative

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What are the Elements of an Informed Consent Form?

A
  1. Purpose
  2. Procedures involved
  3. Experimental parts
  4. Risks & Benefits
  5. Alternative options
  6. Statement that this is voluntary
  7. How confidentiality will be maintained
  8. Compensation/TX for injury if > minimal risk
  9. Who to contact for clinical concerns and subject rights
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Documentation of Informed consent

A

Sign and Date
Date of IRB approval
Subject given a copy of the written consent document

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

ICF Short Form

A

Requires witness at the oral presentation of the ICF to the subject
Consenter: Signs a copy of the summary
Subject :Signs Short form
Witness: Signs both the Short form and a copy of the summary

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What is CFR 21 Part 50 Subpart D?

A

Additional Safeguards for Children and Includes wards of state, but they must have an advocate assigned and have no relation to the trial

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Safeguards for Clinical Trials Involving Children

A

Studies are ok if they have minimal risk or if > than minimal risk , present prospect of direct benefit to subject.
Benefit must be favorable vs. alternative options
Adequate provisions are made for solicitation of assent from kids /parent
Or greater than minimal risk and no direct benefit but generalizable knowledge at subjects condition will be gained.
IRB accounts for AGE, MATURITY and PSYCHOLOGIAL state of kids involved i.e.. assent of the child is not necessarily needed to proceed

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

What is CFR 21 Part 56?

A

Institutional Review Boards

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

What investigations/scenarios are exempt from IRB review?

A
  1. Investigations commenced prior to July 27, 1981
  2. Emergency use of test articles and must be reported within 5 days
  3. Consumer acceptance studies. (Taste, food quality and etc.) Food ingredients must be at or below safe levels approved by FDA
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

What is CFR 21 Part 56 Subpart B?

A

IRB Registration and membership

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Who should the IRB register to initially? How often do they need to renew their registration?

A

IRB’S must be registered at a site maintained by the Department of Health and Human Services and must renew registration with DHHS every 3 years

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

What information should the IRB have in order to be registered?

A
  1. Site’s name and Address
  2. Name, address, phone, fax and email of senior officer at the institution. (Must be revised within 90 days if any change and revised information should be sent to FDA)
  3. # of active protocols under initial and /or continuing review or expedited review (I.e active protocols)
  4. Description of product types in active protocols. If new products/protocols are picked up it must be reported within 30 days
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

How often should an IRB Re-Register?
Bonus Question!!! 😁

A

Every 3 years.
Bonus: IRB is registered after review and acceptance by Department of Health and Human Services

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

How can IRB registration occur?

A

Electronically or by mail to the office of GCP in MD

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

How many days does an IRB have to notify if disbanding? Who do they notify?

A

30 days to notify the FDA

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

IRB Membership

A
  1. Must have greater than or equal to 5 members with varying backgrounds, which is an effort to be nondiscriminatory and protect vulnerable subjects.
  2. No IRB shall have all women or all men or a single profession in its membership
  3. At least 1 member with concerns in a scientific area
  4. At least 1 member in a non scientific area
  5. At least 1 member who is in no way affiliated with the institution
  6. No members with a protocol related conflict of interest.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

IRB Functions and Operations

A

IRB must have written SOPS for reporting and monitoring requirements
IRB must have convened meetings with majority of members present for protocol review EXCEPTION: Expedited review

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

Who give approvals or disapprovals for protocols?

A

The IRB has authority.
IRB can also request modification requirements for protocols

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

What is a continuing review?

A

A review of a protocol that is conducted by the IRB at intervals appropriate to the degree of risk.

29
Q

What are the criteria for an IRB to approve Research?

A
  1. Risks to subjects are minimized and procedures are sound and ideally already in practice
  2. Risks are reasonable when considering the benefits
    3.Selection of subjects is equitable
  3. ICF will be used for all subjects and the use of ICF is documented
  4. Research has a sound plan for data collection and monitoring
  5. Provisions are in place to protect subject privacy and confidentiality
  6. Welfare of vulnerable population is protected and coercion is prevented
30
Q

Who must the IRB notify to suspend or terminate a study?

A

Notify the investigator and the FDA

31
Q

What is CFR 21 Part 56 subpart D?

A

IRB Records and Reports

32
Q

How long should the IRB maintain records after study completion?

A

Greater than or equal to 3 years after study completion and should be available for FDA inspection

33
Q

What is a 1571?

A

IND Application form

34
Q

What is a 1572?

A

Statement of the investigator

35
Q

What is CFR 21 Part 312?

A

Investigational New Drug Application

36
Q

What is an IND?

A

Investigational New Drug

37
Q

What are the exemptions for IND application?

A

No need for IND for clinical investigation of a drug already lawfully marketed in the US. (This applies as long as the investigation is NOT looking at NEW applications for a drug.
Does not involve new risky dose levels or method of administration or presents a higher risk to the population.
In vitro diagnostic biological products
Drugs involving test in invitro or lab research and studies with placebos
The FDA can also issue guidance on whether IND application is warranted

38
Q

How should an IND be labeled?

A

Package containing IND for Human use must be labeled “Caution: New Drug- Limited by Federal or US law to investigational use.”
Cannot have an y misleading or false language
Cannot falsely represent the drug as safe or effective

39
Q

What are the parameters when promoting INDs?

A
  1. Sponsors and investigators can NOT promote a IND or promote its safety or efficacy for the purposes of which it is under investigation
  2. Sponsors and investigators shall NOT commercially test market or distribute propaganda
  3. Sponsor shall NOT unduly prolong investigation after results of study have established sufficient data to support marketing application
40
Q

What are the phases of an investigation?

A

Pre-Clinical
Phase I
Phase II
Phase III
Phase IV

41
Q

What is a phase 1 Trial?

A

Introduction of drug to human subjects
Goal: To determine dosing and metabolism of drug and side effects

42
Q

What is a phase 2 Trial?

A

Safety and efficacy
Goal: Determine common side effects and risks. See how effective drug is for treatment of a specified indication

43
Q

What is a phase 3 Trial?

A

Expanded Cohort
Goal: Generalize and gather further safety and efficacy information using a larger population to determine overall risk vs. benefit
Test for long-term effectiveness and compare to other medications/ treatments

44
Q

What is a phase 4 trial?

A

Provide additional information on efficacy and safety and risk after FDA approval

45
Q

What is an Investigator’s Brochure?

A

Description of drugs formula, toxicology, pharmacokinetics, risks and side effects of investigational drug

46
Q

Who submits an IND Submission?

A

The Sponsor must submit original & 2 copies of all submissions of the IND File including all amendment reports

47
Q

What is a protocol amendment?

A

Any changes made to the protocol. IRB must review and approve
Can submit amendments in 30-day intervals when able

48
Q

What is form FDA 1571?

A

IND Application

49
Q

IND Safety reporting: How man days does a sponsor have to notify the FDA and Investigator of an SAE?

A

Sponsor must notify FDA and Investigator about potential serious risks (SAE’S) no later than 15 days

50
Q

What does the Sponsor need to report to FDA and Investigator in regard to an SAE?

A
  1. Serious and unexpected AEs
  2. Suspected AEs if evidence suggests they are related to study drug
    This includes findings from other studies and in vitro studies and animal testing
51
Q

How must a sponsor submit an SAE?

A

Sponsor must submit to FDA via narrative/electronic format or on FDA form 3500A for review and archiving

52
Q

How many days does a sponsor have to submit an unexpected Fatal/ Life threatening SAE?

A

Submit within 7 days of discovery

53
Q

Annual Reports*

A

Sponsor must submit progress report within 60 days of IND going into effect
Must include summary of protocol and study updates (Data/patients/safety info)

54
Q

When can a sponsor withdraw an IND?

A

At any time but must notify FDA, IRB and investigators

55
Q

When does an IND go into effect after FDA receives IND?

A

30 days unless FDA notifies sponsor otherwise

56
Q

What is the 1572?

A

Statement of the investigator.
1. This form is required for trial’s involving biologics or investigational drugs.
2. Investigator provides his/her qualifications, information on clinical site and assurance to conduct trial according to FDA regulations.

57
Q

When does a 1572 need to be updated?

A

When there is a new site or a new investigator or when replacing an investigator.
The investigator provides this to the sponsor who then has a 30 day window to submit to FDA.
When the site’s IRB or affiliated lab or other resources change.
If PI/ Sub-I name changes (marriage) may utilize NTF or update 1572
All staff on 1572 must have current CV’s within 2 years.

58
Q

What is the FDA regulatory form 3454?

A

This form is completed if NONE of the investigators have FDA required disclosures that are significant

59
Q

What is the FDA regulatory form 3455?

A

This form is completed if any clinical investigator DOES have a financial disclosure that is significant

60
Q

When should a sponsor collect either the FDA form 3454 or 3455?

A

Must collect this information PRIOR to an investigators participation in the clinical trial.
Investigator will also provide updates up to 1 year after study closure

61
Q

What is the FDA Regulatory Form 3500?

A

A form used by professionals to submit all reports not mandated by Federal law.
This is not required by them except when reporting of vaccine related AE’s/reactions

62
Q

What is the FDA regulatory Form 3500A?

A

A form used for the reporting UNEXPECTED AE’s or SAE’s related to study drug
1. Investigator reports the event to IND holder(Sponsor) and IRB
2.Sponsor reports event to FDA
3. If unexpected and related SAE: Sponsor must send 3500A with in 7 days
4. Other unexpected and related SAE’s submit 3500A with in 15 days of finding out

63
Q

What is a 482 form?

A

Notice of inspection

64
Q

What is a 483 form?

A

Inspectional Observations

65
Q

What is 3454 form?

A

Financial disclosure form if you have none to disclose

66
Q

What is a 3455 form?

A

Financial disclosure form if you DO have items to disclose

67
Q

What is a 3500 form?

A

Medwatch form used by Health professionals and is voluntary

68
Q

What is a 3500A form?

A

Mandatory form for unexpected and related Ae’s and SA’s

69
Q

What is Part 46?

A

Protection of Human subjects
1. Pregnant women and fetuses
2. Prisoners
3 Children

SOCRA Certification (1 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions