MSU HRPP Manual Section 7-9-C

Not later than 30 calendar days after:

Change in overall recruitment status

Overall Recruitment Status

Clinical trial reaches its actual primary completion date

Primary Completion Date

Not less than once every twelve months:

Changes to the registration information that was required at the time of submission

Registration data elements that were required at the time of submission (specified in 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii))

Not later than 15 calendar days after:

Change in device approval or clearance status has occurred

Device Product Not Approved or Cleared by U.S. FDA

Not later than 30 calendar days after: 

First human subject is enrolled (if the first human subject was not enrolled in the clinical trial at the time of registration)

Study Start Date

A non-proprietary name is established for any intervention included in the Intervention Name(s) data element

Intervention Name(s)

Any change in overall recruitment status

Overall Recruitment Status

Overall Recruitment Status is changed to “suspended,” “terminated,” or “withdrawn,”

Why Study Stopped

Change in status for any individual site

Individual Site Status

Change in status for human subjects protection review board

Human Subjects Protection Review Board Status

Clinical trial reaches its actual primary completion date

Primary Completion Date

Primary completion data changed to “actual”

Enrollment data element specifying the actual number of participants enrolled

Clinical trial reaches its actual study completion date

Study Completion Date

Change in the Responsible Party or the official title of the Responsible Party

Responsible Party, by Official Title

Change in the Responsible Party or the contact information for the Responsible Party

Responsible Party Contact Information

Protocol is amended in such a manner that changes are communicated to human subjects in the clinical trial and the protocol amendment is approved by a human subjects protection review board

Updates to any relevant clinical trial registration information data elements

Not less than every 12 months:

Changes to clinical trial registration information

Registration data elements that were required at the time of submission (specified in 42 CFR 11.28)

Not less than every 12 months, or any time the Responsible Party reviews the complete set of submitted clinical trial information for accuracy:

Any time the Responsible Party reviews the complete set of submitted clinical trial information for accuracy, even if no other updated information is submitted at that time

Record Verification Date

Not later than 30 calendar days after:

Expanded access becomes available, if expanded access to an investigational drug product (including a biological product) becomes available after an applicable clinical trial of that product has been registered, the Responsible Party, if both the manufacturer of the investigational drug product (including a biological product) and the sponsor of the applicable clinical trial

Availability of Expanded Access data element for that applicable clinical trial and, unless an expanded access record has already been created as required by § 11.28(a)(2)(ii)(H), submit the data elements in accordance with § 11.28(c) to create an expanded access record

Date on which the Responsible Party receives an NCT number for an expanded access record (created as required by 42 CFR 11.28(a)(2)(ii)(H))

Availability of Expanded Access data element by entering the NCT number in the clinical trial record for the applicable clinical trial 

Change in the availability of expanded access to an investigational drug product (including a biological product) under section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb)

Expanded Access Status, under § 11.28(c)(2)(iv) (Expanded Access Record)

Change in the type(s) of expanded access available for an investigational drug product (including a biological product) under section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb).

Expanded Access Type, under § 11.28(c)(1)(x) (Expanded Access Record)

When Results Information Initially Submitted

Clinical trials registration information

If the clinical trial was initiated on or after January 18, 2017, update clinical trial registration information in accordance with 42 CFR 11.64(a)(1)(ii)If the clinical trials was initiated before January 18, 2017, update linical trial registration information in accordance with 42 CFR 11.64(a)(1)i)

Not less than once every 12 months.

Changes to required clinical trial results information, other than:·        

• Protocol and statistical analysis plan specified in 42 CFR 11.48(a)(5) and
• Certain agreements specified in 42 CFR 11.48(a)(6)(ii)

Required results data elements

Not later than 30 calendar days after:

A non-proprietary name is established for any intervention included in the Intervention Name(s) data element. 

Intervention Name(s) Intervention name must be updated to a non-proprietary name

Clinical trial reaches its actual primary completion date

Primary Completion Date At the time the date is changed to “actual,” the Enrollment data element specifying the actual number of participants enrolled must be submitted

Clinical trial reaches its actual study completion date

Study Completion Date

Any change in overall recruitment status

Overall Recruitment Status If, at any time, Overall Recruitment Status is changed to “suspended,” “terminated,” or “withdrawn,” the Responsible Party must also submit the Why Study Stopped data element.

Not less than every 12 months, or any time the Responsible Party reviews the complete set of submitted clinical trial information for accuracy:

Any time the Responsible Party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time

Record Verification Date

Not later than 15 calendar days after:

Notification by ClinicalTrials.Gov of all apparent errors, deficiencies, and/or inconsistencies identified in the notification for clinical trial registration information

Registration information

A Responsible Party who becomes aware of errors, other than those provided through the ClincialTrials.Gov quality control process, in any clinical trial registration information

Registration information

Not later than 25 calendar days after:

Notification by ClinicalTrials.Gov of all apparent errors, deficiencies, and/or inconsistencies identified in the notification for clinical trial results information

Results information

A Responsible Party who becomes aware of errors, other than those provided through the ClincialTrials.Gov quality control process, in any clinical trial results information

Results information