Background:
Clinical trials require serious adverse events-(SAE) reporting to occur within 24hrs of site being aware of SAE occurrence. On Weekends and public holidays the inability to comply with this deadline often results in sites having protocol violations. Most investigator-clinicians find it impractical to submit SAE’s into the Electronic Case Report Form-(eCRF).
Aim:
To examine investigator-clinicians attitudes towards afterhour’s data-entry into eCRF’s for SAE reporting. And to identify alternative strategies which could be implemented to comply with safety requirements.
Methods:
An online survey, using survey monkey, of investigator-clinicians over 2 institutions was conducted to identify their attitudes towards afterhours SAE date entry into the eCRF.
Investigator-clinicians attitude to potential alternative, strategies/solutions was also sought via the same survey.
Results:
15 of 18 (83%) investigator-clinicians responded to the online survey.
13 (87%) of responders had not previously entered an SAE into the eCRF.
With 13 (87%) the main reason for not entering in SAE’s were that they were not familiar with the eCRF.
7 (47%) stated that they could not remember their username/password and eCRF link.
7 (47%) stated that they could not remember the patient’s trial number.
Possible solutions:
13 (87%) of investigator-clinicians stated the most practical approach to fulfill the SAE reporting timelines is to email the Medical Monitor and Global safety-Team.
7 (47%) investigator-clinicians wanted the Sponsors to change the 24hr SAE reporting requirement to be the next business day.
With 3 (20%) investigator-clinicians wanting to employee an on-call trial co-ordinator to submit SAEs after hours.
Conclusions:
Based on the results of this survey the implementation of policies allowing investigator-clinicians to email the Medical-Monitor and Global Safety-team about SAE’s on Weekends/Public Holidays would lead to higher compliance as opposed to data entry into an eCRF, reducing protocol violations and meeting safety requirements.