Summary

/ Site 1 / Site 2 / Site 3 / Site 4 / Site 5 / Site 6 / Site 7 / Overall
Recruitment Score
Protocol Adherence Score
Study Completion Score
Data Quality Score
Timeliness Score
Weighted Average of Scores1

1Weights are as follows: recruitment (.25), protocol adherence (.15), study completion (.25), data quality (.25), timeliness (.10).

Recruitment

/ Site 1 / Site 2 / Site 3 / Site 4 / Site 5 / Site 6 / Site 7 / Overall

A Study

1. Contribution to Total Enrolled (%)
2. Share of Ideal Contribution (%)1
3. Consent Rate of Eligible Patients (%)
4. Average of rows 2 and 3 (%)
B Trial
1. Contribution to Total Enrolled (%)
2. Share of Ideal Contribution (%)1
3. Consent Rate of Eligible Patients (%)
4. Average of rows 2 and 3 (%)
C Trial
1. Contribution to Total Enrolled (%)
2. Share of Ideal Contribution (%)1
3. Consent Rate of Eligible Patients (%)
4. Average of rows 2 and 3 (%)
D Trial, Observation Phase
1. Contribution to Total Enrolled (%)
2. Share of Ideal Contribution (%)1
3. Consent Rate of Eligible Patients (%)
4. Average of rows 2 and 3 (%)
All Studies
Recruitment Score (%)2

1Row 1  c, where c = number of centers participating. Ideally, each center would enroll equal proportions (1/7) of patients.
2Mean of row 4 across studies.

Protocol Adherence1

/ Site 1 / Site 2 / Site 3 / Site 4 / Site 5 / Site 6 / Site 7 / Overall
A Study
1. Subjects without major violations (%)
B Trial
1. Subjects without major violations (%)
C Trial
1. Subjects without major violations (%)
D Trial, Observation Phase
1. Subjects without major violations (%)

All Studies

Protocol Adherence Score (%)2

1Major violations related to clinically required care are excluded.

2Mean of row 1 across studies.

Study Completion

/ Site 1 / Site 2 / Site 3 / Site 4 / Site 5 / Site 6 / Site 7 / Overall
A Study
1. Subjects with primary outcome collected (%)1
B Trial
1. Subjects with primary outcome collected (%)1

All Studies

Study Completion Score (%)2

1Denominator excludes subjects who are deceased. For studies where mortality is the primary endpoint, this rating will enumerate the number of
survivors who are followed for the time period that is required to observe the primary endpoint (e.g., one-year mortality).

2Mean of row 1 across studies.

Data Quality

/ Site 1 / Site 2 / Site 3 / Site 4 / Site 5 / Site 6 / Site 7 / Overall

A Study

1. Data entry accuracy rate (%)1
2. Forms completely processed at initial entry (%)2
3. Echo image assessed as good or excellent (%)
4. MRI image assessed as good or excellent (%)
5. Average of rows 1 to 4 (%)

B Trial

1. Data entry accuracy rate (%)1
2. Forms completely processed at initial entry (%)2
3. Echo image assessed as good or excellent (%)
4. Average of rows 1 to 3 (%)

C Trial

1. Data entry accuracy rate (%)1
2. Forms completely processed at initial entry (%)2
3. Echo image assessed as good or excellent (%)
4. Average of rows 1 to 3 (%)

D Trial, Observation Phase

1. Data entry accuracy rate (%)1
2. Forms completely processed at initial entry (%)2
3. Average of rows 1 and 2 (%)

All Studies

Data Quality Score (%)3

1Percentage of fields entered correctly, as determined by double data entry of selected forms.

2Forms that were completely processed (no pending edits) on the same day they were data entered into ADEPT. Excludes forms not expected to be
data entered all at once (e.g. adverse event forms).

3Mean of last row across studies.

Timeliness

/ Site 1 / Site 2 / Site 3 / Site 4 / Site 5 / Site 6 / Site 7 / Overall

A Study

1. Study Implementation Score (%)1
2. Study Forms received on time (%)2
3. Average of rows 1 and 2 (%)
B Trial
1. Study Implementation Score (%)1
2. Study Forms received on time (%)2
3. Average of rows 1 and 2 (%)
C Trial
1. Study Implementation Score (%)1
2. Study Forms received on time (%)2
3. Average of rows 1 and 2 (%)
D Trial, Observation Phase
1. Study Implementation Score (%)1
2. Study Forms received on time (%)2
3. Average of rows 1 and 2 (%)
All Studies
Timeliness Score (%)3

1Calculated based on a goal of first screened patient occurring 60 days after central training. A score of 100% = 60 days. Higher scores reflect earlier
first screening, and lower scores reflect later first screening, using the formula [60/days]100%, where days = number of days from central training to
first screening.

2Excludes Core Laboratory Forms and Screening Forms. Forms entered into ADEPT > 14 days after the specified window are considered late.

3Mean of row 3 across studies.