Benefits of ePRO versus Paper Diaries
Prior to the development and implementation of IVRCC’s Electronic Patient Diaries, the only option for patients was to keep a daily paper diary throughout the study; they were requested to record symptoms when they experienced them, however, often times the sites and the sponsors questioned when they were filled out.
Thus these paper diaries have several major drawbacks, whereas the IVRCC Electronic Patient Diary provides a number of advantages and efficiencies:
- Paper patient diaries cannot be tracked for adherence to the reporting schedule; if the patient forgets to complete the diary on the date the symptom occurred, they can complete the diary later, increasing the likelihood that data entered is inaccurate.
- The IVR protocol often defines a window of time during which the patient reports symptoms that they are experiencing at the moment or within the previous 12-24 hours. Reporting parameters are set depending where on the globe the patient resides. Each patient entry is time stamped with the patient’s local time documenting exactly when the call was made.
- The data reporting structure surrounding paper diaries is slow, and costly; the diaries are brought in at routine visits in intervals of weeks or months, and the onus is placed on the investigative site to oversee compliance and uncover anomalies in the data. By the time these aberrations are discovered, the patient can no longer remember the correct response and important data is lost which can impact the outcome of the study.
IVRCC’s ePRO is programmed to generate an alert when data is entered which is invalid or outside accepted ranges. Respondents are immediately prompted to re-enter data. Thus, conflicts are resolved remotely and instantly.