Misc Info

Question 1

Who is allowed to review and make copies of records relating to the clinical investigation

Answer 1

The sponsor the FDA the IRB, and the DEA for a controlled substance

Question 2

If informed consent is foregone to preserve life/limb the investigator must know the IRB within how long and include independent MD review

Answer 2

5 working days

Question 3

If the test article used without consent is a device, the investigator must submit written notification to IRB and FDA within

Answer 3

5 working days

Question 4

If fda issues an investigator a Form 483 the response should _______________ and be submitted within ________.

Answer 4

Address each listed grievance, provide a timeline for correction or request clarification

Response must be submitted with 15 business days

Question 5

FDA form 1572

Answer 5

Statement of investigator that acts as a legal commitment that investigator will comply with all regulations and requirements of a clinical trial.

Question 6

FDA form 3454: CERTIFICATION of financial interests and arrangements of clinical investigators

Answer 6

Sponsor to certify no financial arrangements have been made with clinical investigators that could affect the outcome of the study, and that participating CIs have not disclosed any proprietary interests in study.

Question 7

Form FDA 3455 DISCLOSURE: Financial interests and arrangements of clinical investigators

Answer 7

Statement by investigator to disclose any financial interests or arrangements that may influence study outcome. Includes interests of spouse and dependent children.

Question 8

FDA form 3500 and 3500A

Answer 8

Used for voluntary reporting of AEs to the FDA.
A- used for mandatory reporting. Sponsor has 15 calendar days to to respond to additional info requests from FDA

Question 9

In the moment, Informed consent may be waived under the following circumstances:

Answer 9

1. Life or death situation
2. Pt unable to communicate
3. Insufficient time to locate LAR
4. No available approved alternative for saving life or limb

Question 10

ICF exception for emergency use must include

Answer 10

1. IRB approved procedures for notifying pt, lar, and family of emergent inclusion. Disclosure of inclusion must happen and they can still WD at anytime.

Question 11

Criteria for documenting short form consent:

Answer 11

Elements to be presented orally in front of a witness. Sub signs short form. The witness signs short form and summary. Person obtaining consent signs summary. Sub provided with copies.

Question 12

Conditions under which assent maybe waived even if IRB deems appropriate

Answer 12

1. Investigation no more than minimal risk
2. Waiver will not affect rights or welfare
3. Investigation not practical without a waiver
4. Additional pertinent info will be provided when available.

Question 13

Phase 1 of IND investigation

Answer 13

Phase 1- initial intro of drug to humans. Assess pharmacokinetics, dosage side effects and effectiveness.

Question 14

Phase 2 IND trial

Answer 14

Well controlled, closely monitored, several hundred enrolled. Focus on effectiveness for defined indication, and id’ing side effects and associated risks.

Question 15

Phase 3 IND

Answer 15

Expanded controlled and uncontrolled trials. Gather additional safety and efficacy data to provide basis for labeling. Enrolls hundreds to thousands.

Question 16

Important medical events for AE reporting

Answer 16

Event can be considered a serious AE as determined by the investigator. Can include development of drug dependency or drug abuse.

Question 17

Serious and unexpected suspected adverse reactions are:

Answer 17

SAR that is both serious and unexpected. Reported as a SUSAR if evident relationship between drug and AE such as single occurance of uncommon event but strongly associated with drug exposure. More than one event occurance not common with drug exposure. Indication that event occurs more frequently with drug treatment group vs. Control.

Question 18

IND inactive status

Answer 18

Investigations under an IND that have been on hold for a year or more may be moved to inactive status. Can be terminated after 5 years.

Question 19

Grounds for IND termination

Answer 19

Exposure to unreasonable or significant risk. Insufficient info for assessing sub safety. Inadequate manufacturing controls. Noncompliance, falsifying, or omitting. Failure to delay or suspend investigation on clinical hold. Evidence that drug is not effective,

Question 20

Exporting insulin and antibiotics

Answer 20

May be exported for investigational use without complying with typical exporting requirements

Question 21

Significant equity interest amount

Answer 21

> 50,000

Question 22

What are the 3 principles of the Belmont report

Answer 22

Respect for persons
Beneficence
Justice