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 PACTR (Africa), TrialScope Disclose includes the following rules:

Assess if Protocol Registration is needed on PACTR (Africa)

Automatically assess Protocol Registration for PACTR for Interventional and Observational studies conducted in an African nation that have started on or after September 9, 2009.

African Regions include: Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cabo Verde, Cameroon, Central African Republic, Chad, Comoros, Congo, Cote dIvoire, Djibouti, Egypt, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Kenya, Lesotho, Liberia, Libya, Madagascar, Malawi, Mali, Mauritania, Mauritius, Morocco, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Tanzania, Togo, Tunisia, Uganda, Zambia, Zimbabwe

Initial Protocol Law Due Date on PACTR (Africa)

PACTR (Africa) Protocol Registration is assessed, disclosure needs to be posted on PACTR 1 day prior to study start date.

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