Best Practices to Drive Time and Cost Savings for Contraceptives | Page 12

Figure 9.

TRIAL
PARTICIPANT

ePRO
PLATFORMS

Technology-Enhanced Data Quality in Women’s Health Clinical Trials

EDC
TEMPO

DAILY ePRO
DATA ENTRY

RISK-BASED MONITORING

BENEFITS
Participants answer
questions via mobile, browser
app or dedicated device

Real-time monitoring
at study sites
Identify compliance issues

When did you
use the pill last?

Identify outliers

Have you had
sex today?

Yes
No

Generate
performance reports

Are you experiencing
bleeding or spotting?

Yes
No

Send automatic reminders
to participants

-Please complete
yesterday’s diary.

SAVES TIME
AND MONEY

Despite the need to ensure compliance, it can be difficult to monitor. Historically, participants kept written diaries; however, these can be
cumbersome and impractical. As a result, they may not be completed on a daily basis, and participants may attempt to backfill their diaries,
resulting in recall issues. When the diaries are only collected monthly, during the participant’s scheduled visit, the data could be significantly
compromised.
The use of electronic diaries (e-diaries), also referred to as electronic patient reported outcomes (ePRO), is gaining popularity and acceptance in a
number of clinical trials, but particularly in clinical contraception trials, which depend on near daily recording of data. The use of e-diaries reduces
the participant burden associated with documenting product use, endpoints, side effects, and other required data and improves compliance and
retention. Consider this scenario: the participants enter their diary information. Once they complete the entry, the information is transmitted to
the server and collated overnight in TEMPO. The following morning, tailored reports are available (e.g., per site and overall, total enrollment, list
of participants who did not submit a diary entry, list of participants who missed >x% of pills over a period of time), and the monitor can contact
specific sites or provide the sites with a list of participants to follow up. A site visit can be planned, if necessary.

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