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 PharmNet.Bund/BfArM/PEI (Germany), TrialScope Disclose includes the following rules:

Assess if Protocol Registration is needed on PharmNet.Bund (Germany) for an observational study starting after August 2013

Automatically assess Protocol Registration on PharmNet.Bund for Observational studies conducted in Germany that have started on or after August 13, 2013.

Assess if Protocol Registration is needed on PharmNet.Bund (Germany) for an observational study that started on or after August 13, 2013 or completed on or after December 31, 2013

Automatically assess Protocol Registration on PharmNet.Bund for Observational studies conducted in Germany that have started before August 13, 2013 and completed on or after December 31, 2013

Assess if Results are needed on PharmNet.Bund (Germany) for an Interventional trial with product authorized and study completed before Jan 1, 2011

Automatically assess Results Disclosure on PharmNet.Bund for Interventional studies with a Product Market Authorization in Germany or European Union that has approval date before January 1, 2011.

Assess if Results are needed on PharmNet.Bund (Germany) for an Interventional trial for an unapproved product that was authorized and study completed after Jan 1, 2011

Automatically assess Results Disclosure on PharmNet.Bund for Phase 2-4 Interventional studies with a Product Market Authorization in Germany or European Union that has approval date before January 1, 2011.

Assess if Results are needed on PharmNet.Bund (Germany) for an Interventional trial for an approved product that was completed on or after Jan 1, 2011

Automatically assess Results Disclosure on PharmNet.Bund for Interventional studies that have a Study Completion Date of January 1st 2011; Product Market Authorization in Germany or European Union and approval date is on or before Study Completion Date.

Assess if Results are needed on PharmNet.Bund (Germany) for an observational study that started on or after August 13, 2013 or completed on or after December 31, 2013

Automatically assess Results Disclosure on PharmNet.Bund for Observational studies conducted in Germany that started on or after August 13, 2013; or started before August 13, 2013 and completed on or after December 3, 2013.

Initial Protocol Law Due Date for an observational study starting after August 2013 on PharmNet.Bund (Germany)

PharmNet.Bund (Germany) Protocol Registration is assessed, disclosure for Observational studies that have started after August 2013 need to be posted on PharmNet.Bund 1 day prior to study start date.

Protocol Disclosure Due date for “Law” will be set to Study Start Date – 1 Day.

Initial Protocol Law Due Date for an observational study that started on or after August 13, 2013 or completed on or after December 31, 2013 on PharmNet.Bund (Germany)

PharmNet.Bund (Germany) Protocol Registration is assessed, disclosure for Observational studies that have started after August 2013 and completed after December 31, 2013 need to be posted on PharmNet.Bund before January 1, 2014.

Protocol Disclosure Due date for “Law” will be set to January 1, 2014.

Initial Results Law Due Date for an Interventional trial for an approved product that was completed on or after Jan 1, 2011 on PharmNet.Bund (Germany)

PharmNet.Bund (Germany) Results are assessed. Disclosure for Interventional studies that have a Study Completion Date of January 1st 2011; Product Market Authorization in Germany or European Union and approval date on or before Study Completion Date must be disclosed one year after Study Completion

Results Disclosure Due date for “Law” will be set to Study Completion Date + 1 year.

Initial Results Law Due Date for an Interventional trial for an unapproved product that was authorized and study completed after Jan 1, 2011 on PharmNet.Bund (Germany)

PharmNet.Bund (Germany) Results are assessed. Disclosure for Interventional Phase 2-4 studies with a Product Market Authorization in Germany or European Union that has approval date after Study Completion and Approval Date is on or after January 1, 2011 must be disclosed on the earliest of the German or EU Authorization Date + 6 months.

Results Disclosure Due date for “Law” will be set to Earliest of the German or EU Authorization Date + 6 months.

Initial Results Law Due Date for an Interventional trial with product authorized and study completed before Jan 1, 2011 on PharmNet.Bund (Germany)

PharmNet.Bund (Germany) Results are assessed. Disclosure for Interventional studies that have a Study Completion Date of January 1st 2011; Product Market Authorization in Germany or European Union and approval date January 1, 2011 must be disclosed by July 1, 2012.

Results Disclosure Due date for “Law” will be set to July 1, 2012.

Initial Results Law Due Date for an observational study that started on or after August 13, 2013 or completed on or after December 31, 2013 on PharmNet.Bund (Germany)

PharmNet.Bund (Germany) Results are assessed. Disclosure for Observational studies that have started after August 2013 and completed after December 31, 2013 need to be posted 12 months after Study Completion Date.

Results Disclosure Due date for “Law” will be set to Study Completion Date + 12 Months.