SUMMARY

TrialScope Disclose includes a set of standard assessment and due date rules that can be enabled/disabled which help customers comply with their obligation to disclose clinical trial information.

For ClinicalTrials.gov, TrialScope Disclose includes the following rules:

Assessments:

Compliance Due Dates

Automatically assess if a study is an Applicable Clinical Trials (ACT) per the Final Rule (21 CFR Part 42) and requires registration on ClinicalTrials.gov. An ACT trial is an interventional, phase 2-4 trial that started on or after January 18, 2017 that is a US-regulated drug or device and is executed with an IND, has a US-based location, or study product is manufactured and exported from the US.

Automatically assess if a study is a Probable Applicable Clinical Trials (pACT) per FDAAA 801 and requires registration on ClinicalTrials.gov. A pACT trial is an interventional, phase 2-4 trial that started on or after September 27, 2007 and before January 18, 2017 that is either executed with an IND or has a US-based Region (or no Region).

Automatically assess if an interventional study with an IND studying a drug in a region of United States, Northern Mariana Islands, American Samoa, Guam, Puerto Rico or US Virgin Islands requires registration on ClinicalTrials.gov. Study must have started before September 27, 2007 and primary completion date of December 26, 2007 of an FDA Regulated drug product to require assessment.

Automatically assess if a study is a Pediatric post-market surveillance of a device product that is not a clinical trial per the Final Rule (21 CFR Part 42) and requires registration on ClinicalTrials.gov. Studies applicable to this rule have started on or after January 18, 2017, with a US Region and has “Post-Authorization Type” =‘Safety’ or ‘Efficacy’ or ‘Safety and Efficacy’ and “Studies a device product” = ‘Yes’, and “Pediatric” = ‘Yes’.

Automatically assess if an interventional study with a region in Israel requires registration on ClinicalTrials.gov. Study must have started before September 4, 2005 and have a product type of Drug, Biological, procedure, Genetic or Device to require disclosure.

Automatically assess if an interventional study with a region in Turkey requires registration on ClinicalTrials.gov. Study must be phase 2-4, have started on or after December 26, 2007 and have a product type of Drug, Biological, or Device to require disclosure.

Automatically assess if a study is an Applicable Clinical Trials (ACT) per the Final Rule (21 CFR Part 42) that requires results disclosure on ClinicalTrials.gov. An ACT trial is an interventional, phase 2-4 trial that started on or after January 18, 2017 that is a US-regulated drug or device and is executed with an IND, has a US-based location, or study product is manufactured and exported from the US and the “Overall Recruiting Status” is not ‘Withdrawn’

Automatically assess if a study is a Probable Applicable Clinical Trials (pACT) per FDAAA 801 that requires results disclosure on ClinicalTrials.gov. Results are required if a study is an interventional, phase 2-4 trial that started on or after September 27, 2007 and before January 18, 2017 or the Primary Completion Date is between December 25, 2007 and January 17, 2017, that is either executed with an IND or has a US-based Region (or no Region).

Automatically assess if results are needed for a Pediatric post-market surveillance of a device product that is not a clinical trial per the Final Rule (21 CFR Part 42) and requires results disclosure on ClinicalTrials.gov. Studies applicable to this rule have started on or after January 18, 2017, with a US Region and has “Post-Authorization Type” =‘Safety’ or ‘Efficacy’ or ‘Safety and Efficacy’ and “Studies a device product” = ‘Yes’, and “Pediatric” = ‘Yes’.

Automatically assess if an interventional study with a region in Israel requires results disclosure on ClinicalTrials.gov. Studies applicable to this rule must have started before September 4, 2005 and have a product type of Drug, Biological, procedure, Genetic or Device to require results disclosure.

FDAAA requires clinical trial information to be submitted not later than 21 days after enrollment of the first participant. In Disclose, the enrollment of first participant is calculated by the Study Start Date.

Initial Protocol Registration Date: Global Study Start Date + 21 days.

Amendments entered in Disclose are required to be posted on ClinicalTrials.gov within 30 days of the amendment.

Protocol Maintenance Due Date: Date the amendment was added + 30 days (Disclose Releases prior to 2.19.3).

Protocol Maintenance Due Date: Date in the amendments table + 30 days (Disclose Release 2.19.3 and higher).

Protocol QA Comments require a response within 15 days of comments being posted on PRS.

Protocol QA Comments Reponses Maintenance Due Date: Date of the comments entered + 15 days.

When a “Final Rule" field is changed CTGov must be updated 30 days after the date the change was made. Users are required to follow final rule update guidelines for any study posted to CTGov including voluntary postings.

Protocol Maintenance Due Date: Date of the first change + 30 days.

*For additional details on this rule, refer to the “ClinicalTrials.gov 30 Day Data Change Maintenance Rule” QRG

Scheduled Protocol Maintenance occurs every 30 days when the Study Overall Recruitment Status is 'Not Yet Recruiting' or 'Recruiting'.

Protocol Maintenance Due date: Previous Protocol CE Workflow Completion Date (actual if available, or projected) + 30 days.

Scheduled Protocol Maintenance is due every 90 days when the Study Overall Recruitment Status is 'Active, Not Recruiting' or 'Enrolling by Invitation'.

Protocol Maintenance Due Date: Previous Protocol CE Workflow Completion Date (actual if available, or projected) + 90 days.

When a "Final Rule" field is changed CTGov must be updated 30 days after the date the change was made. You are required to follow final rule update guidelines for any study posted to CTGov including voluntary postings.

See ClinicalTrials.gov 30 Day Data Change Maintenance Rule – TrialScope Community (zendesk.com).

Scheduled Protocol Maintenance occurs every year for Interventional studies when the Study Overall Recruitment Status is 'Completed'. Users will be prompted to perform maintenance annually until the Study Completion Date has been reached.

Maintenance date = Previous Protocol CE Workflow Completion Date + 1 year.

FDAAA states that results are required no later than 12 months after the Primary Completion Date. Users are prompted to disclose initial results 1 year after primary completion date.

Initial Results Disclosure Due Date: Primary Completion Date + 365 days

There is a request for delayed results submitted to ClinicalTrials.gov with a Delay Results Type = 'Certify Initial Approval'. Results must be posted to ClinicialTrials.gov based on the delayed results submission upload date + 2 years, or FDA Approval + 30 days – whichever occurs first.

Initial Results Disclosure due date is the earlier of FDA Approval + 30 days or Delayed Results submission + 2 years.

There is a request for delayed results submitted to ClinicalTrials.gov with a Delay Results Type = 'Certify Initial Approval'. Results must be posted to ClinicialTrials.gov 30 days after FDA Approval.

Initial Results Disclosure due date: FDA Approval + 30 days

There is a request for delayed results submitted to ClinicalTrials.gov with a Delay Results Type = 'Certify New Use'. Results must be posted to ClinicialTrials.gov based on the delayed results submission upload date + 2 years, or FDA Approval + 30 days – whichever occurs first.

Initial Results Law Due Date for with a (good cause) Extension delay that is not rejected on CTGOV (USA)

There is a request for delayed results submitted to ClinicalTrials.gov with a Delay Results Type = Extension, the Initial Results Disclosure due date = Delayed Results Extension Date

Initial Results Disclosure due date: Delayed Results Extension Date

There is a request for delayed results submitted to ClinicalTrials.gov with a Delay Results Type = Extension which has been rejected by ClinicalTrials.gov. The Initial Results Disclosure due date is the later of Primary Completion Date + 365 days or the Delayed Posting Rejection date + 30 days.

Initial Results Disclosure due date: later of Primary Completion Date + 364 days or the Delayed Posting Rejection date + 30 days.

Results QA Comments require a response within 25 days of comments being posted on PRS.

Results QA Comments Reponses\ Maintenance Due Date: Date of the comments entered + 25 days.

Scheduled Results Maintenance occurs 365 days after the Study Completion Date is reached, if the Primary Completion Date and Study Completion Date are not equal.

Results Maintenance Due Date: Study Completion Date + 365 days.

* The 30 and 90-day Scheduled Protocol Maintenance Rule has been replaced by the Data Change to Final Rule fields. However, some customers may still be using the Scheduled Maintenance instead of the Data Change rule. Please reach out to Support if you have any questions about your configuration.