TrialScope Disclose: ROI Calculator

Part 1

Your Global Disclosure needs

Number of countries in which clinical research is conducted

Advanced Options

Advanced options give you greater control over the output of this ROI calculator but are optional.

Note: This information has been pre-filled for you with our own best-practice assumptions.

Disclosure Management

Hours

Average # of hours spent per year per registry/country to determine disclosure requirements (not including clinicalTrails.gov/EudraCT)

Average # of hours spent per study to assess disclosure requirements

Average # of hours spent per week for global disclosure tracking & reporting

US/EU Regulations, Articles and Communications

Hours

Interpreting and applying evolving regulation - FDA & EMA

per year

Analyzing and explaining articles by transparency advocates

per year

Stakeholder communication

per year

Part 2

Your Protocol Registration & Results Disclosure requirements

Average # of new protocols/CTAs posted per year (average of last 3 years) that are required by law:

Average # of new protocols/CTAs posted per year (average of last 3 years) that are posted voluntarily:

Average # of enrolling studies per year (recruiting/enrolling by invitation):

ClinicalTrials.gov

New protocols posted per year

Studies per year

Advanced Options

EUDRA CT

New protocols posted per year

Studies per year

Advanced Options

ClinicalTrials.gov

Advanced options give you greater control over the output of this ROI calculator but are optional

Note: This information has been pre-filled for you with our own best-practice assumptions.

Protocol Registration

Average length of study (# of days from start to primary completion):

Number of updates per year for an enrolling study:

Number of updates per year for an ongoing study that is not enrolling:

Results Disclosure

% of voluntarily posted trials for which results are posted (last 3 years)

% of trials where PCD does not equal SCD (last 3 years)

Disclosure Managers

Current Processes

Average time per protocol to manage disclosure for initial registration

Average time per protocol to manage disclosure for protocol updates

Average time per protocol to submit to CTGov

Average time per protocol to manage response to QA Comments initial registration (include data entry)

% of initial protocol registrations that receive QA Comments

Average time per protocol to manage response to QA Comments protocol updates (include data entry)

% of protocol updates that receive QA Comments

Disclosure Managers

Current Processes

Average time per study to manage disclosure for initial result disclosure

Average time per study to manage disclosure for results updates

Average time per study to submit results to CTGov

Average time per study to manage response to QA Comments initial result disclosure (include data entry)

% of initial result disclosures that receive QA Comments

Average time per study to manage response to QA Comments results updates (include data entry)

% of results updates that receive QA Comments

Editors (Data Entry)

Current Processes

Average time per protocol to enter data for initial registration

Average time per protocol to enter data for protocol updates

Editors (Data Entry)

Current Processes

Average time per study to enter data for initial results disclosure

Average time per study to enter data for results updates

Reviewers

Current Processes

Number of Reviewers per initial protocol

Average number of Reviewers per protocol update

Average number of Reviewers per QA comment response

Average time per reviewer per study for initial registration

Average time per reviewer per study for protocol updates

Average time per reviewer per study for QA Comments

Reviewers

Current Processes

Number of Reviewers per study for initial results disclosure

Average number of Reviewers per study for results update

Average number of Reviewers per QA comment for results disclosure

Average time per reviewer per study for initial results disclosure

Average time per reviewer per study for results updates

Average time per reviewer per study for QA Comments

Approvers

Current Processes

Average number of approvers per protocol update

Average number of approvers per QA comment response

Average time per approver per study for initial registration

Average time per approver per study for protocol updates

Average time per approver per study for QA Comments

Approvers

Current Processes

Average number of approvers per results update

Average number of approvers per QA comment response

Average time per approver per study for initial results disclosure

Average time per approver per study for results updates

Average time per approver per study for QA Comments

EUDRA CT

Advanced options give you greater control over the output of this ROI calculator but are optional.

Note:This Information has been pre-filled for you with our best practice assumptions.

Protocol Registration

Average length of study (# of days from start to primary completion):

Number of status updates per year for an enrolling study:

Number of substantial amendments per year for an ongoing study:

Result Disclosure

Average # of new Results due per year (last 3 years) that are Phase 1 studies:

Disclosure Managers

Current Processes

Average time per study to manage CTA for initial submission

Average time per study to manage CTA for substantial amendment

Average time per study to manage CTA for status updates

Average time per CTA to manage response to NHA comments initial submission (include data entry)

% of initial CTA submission that receive NHA comments

Average time per CTA to manage response to NHA comments on CTA substantial amendments (include data entry)

% of CTA substantial amendments that receive NHA comments

Disclosure Managers

Current Processes

Average time per study to manage disclosure for initial result disclosure

Average time per study to manage disclosure for results updates

Average time per study to submit results to EU CTR

Editors(Data Entry)

Current Processes

Average time per CTA to enter data for initial submission

Average time per CTA to enter data for CTA substantial amendments

Average time per CTA to enter data for CTA status updates

Editors (Data Entry)

Current Processes

Average time per study to enter data for initial results disclosure

Average time per study to enter data for results updates

Reviewers

Current Processes

Average number of Reviewers per CTA substantial amendments

Average number of Reviewers per CTA for response to NHA comments

Average time per reviewer per CTA for initial submission

Average time per reviewer per study for CTA substantial amendments

Average time per reviewer per CTA for NHA Comments

Reviewers

Current Processes

Average number of Reviewers per study for results update

Average time per reviewer per study for initial results disclosure

Average time per reviewer per study for results updates

Approvers

Current Processes

Average number of approvers per CTA substantial amendments

Average number of approvers per CTA for response to NHA comments

Average time per approver per CTA for initial submission

Average time per approver per study for CTA substantial amendments

Average time per approver per CTA for NHA Comments

Approvers

Current Processes

Average number of approvers per results update

Average time per approver per study for initial results disclosure

Average time per approver per study for results updates

Part 3

Your Review & Approval Process

Protocol Registration

Number of Reviewers for an initial protocol submission:

Number of Approvers for an initial protocol submission:

Results Disclosure

Number of Reviewers for an initial results submission:

Number of Approvers for an initial results submission:

Advanced Options

Advanced options give you greater control over the output of this ROI calculator but are optional.

Note:This Information has been pre-filled for you with our best practice assumptions.

USD $

Average cost per hour (Editors & Disclosure Managers):

Average cost per hour (Reviewers & Approvers):

Your Personalized ROI Calculations:

You may save approximately per year with TrialScope Disclose!

That's hours saved across protocol registration and results disclosure processes.

Process	Manual Process		TrialScope Disclosure		Hours Saved		Savings
	Hours	Dollars	Hours	Dollars	Hours	% Savings	Dollars	% Savings
Protocol Registration - US/EU (CTA)
Result Disclosure (US/EU)
Disclosure Management
Total