IND Reporting

Question 1

For an IND, how soon should the sponsor report serious unexpected life-threatening safety events to FDA?

Answer 1

7 calendar days.

Question 2

For an IND, how soon should the sponsor report serious unexpected safety events to FDA when not life-threatening?

Answer 2

15 calendar days.

Question 3

For an IND, what form is used for the sponsor reporting serious unexpected safety events?

Answer 3

Form FDA 3500A

Question 4

What does SUSAR stand for?

Answer 4

Suspected unexpected serious adverse reaction

Question 5

For an IND, when do investigators report serious events to sponsors?

Answer 5

As soon as possible (typically stated in protocol).

Question 6

For an IND, when is the annual report is provided to the FDA by the sponsor?

Answer 6

60 calendar days from the anniversary of the IND becoming active.

Question 7

For an IND, when do Investigator’s provide annual report to sponsor?

Answer 7

No time criteria, give to sponsor to submit to FDA.

Question 8

For an IND, when does the Investigator need to submit the final report to the sponsor?

Answer 8

When the study site is finished with the investigation (no specified time constraints).

Question 9

For IDE, when does a sponsor need to report an unexpected adverse device event?

Answer 9

10 working days.

Question 10

For emergency use of a device or drug, where immediate use of the product was required and the patient was not able to be consented, how long does the sponsor have to notify the FDA of the use of the product?

Answer 10

5 working days.

Question 11

For an Significant Risk IDE, how long after the date of finishing the clinical trail does a sponsor have to notify the FDA that they finished the clinical trial?

Answer 11

30 working days.

Question 12

For significant risk IDE, how long after finishing the clinical trial does the sponsor have to submit their final report?

Answer 12

Within 6 months of finishing the trial.

Question 13

For non-significant risk IDEs, does the sponsor need to send a final report to FDA? If so, how long after finishing a trial?

Answer 13

No, only to the IRB and within 6 months of finishing the trial.

Question 14

How often does the investigator need to provide an annual report to the sponsor for an IDE?

Answer 14

At least yearly (this is typically the same as the continuing review provided to the IRB).

Question 15

For IDE, when and to who does the investigator have to submit a final report after finishing a clinical trial?

Answer 15

Investigator submits a final report to the Sponsor AND to the IRB within 3 months of finishing the trial.

Question 16

For a significant risk or non-significant risk IDE, how often does a sponsor need to submit an annual report and to who?

Answer 16

For all IDE’s: At least yearly progress reports to IRB.

For SR IDE’s: At least yearly to IRB AND to FDA.

Question 17

True or False: Reactions which are serious but expected are subject to expedited reporting requirements?

Answer 17

False. Reactions that are serious but unexpected are subject to expedited reporting.

Question 18

Fatal or life-threatening unexpected adverse drug reactions are required to be reported no later than how many days after first knowledge? What about non-life-threatening unexpected ADRs?

Answer 18

Fatal unexpected ADRs: 7 calendar days after first knowledge

Non-fatal serious unexpected ADRs: 15 calendar days after first knowledge

Question 19

What key data elements should be included in expedited reports for serious adverse drug reactions?

Answer 19

1. Patient details
2. Suspected medicinal product
3. Other treatments patient was receiving
4. Details of Suspected ADR
5. Reporter of the event
6. Sponsor details

Question 20

When is unblinding inappropriate in the case of a fatal or serious adverse event?

Answer 20

I a fatal or serious outcome is the primary efficacy endpoint, the integrity of the clinical investigation may be compromised if the blind is broken. It may be advantageous to reach an agreement with regulatory authority not to unblind and expedite reporting.

Question 21

What is form FDA 3500 used for?

Answer 21

Voluntary reporting of an adverse event.