EMAIL ALERTS IN CLINICAL TRIALS

 EMAIL ALERTS IN CLINICAL TRIALS

EMAIL ALERTS:

Email Alerts are the features that are system generated and sends email notifications or alerts to the specified recipients based on the events and conditions that occur during the study in EDC.

ADVANTAGES FOR EMAIL ALERTS IN CLINICAL TRIALS

✓ Email notifications can be triggered before or after the planned date of an event.

✓ Email alerts allows to quickly receive emergency communications and other important information through email.

✓ Email alerts also helps in

survey-based studies

✓ Emails are quick and efficient

✓ Email alerts can send the information to all the recipients at one click

✓ Once the email alert setup is done, special notifications about the particular criteria is not required.

✓ The survey-based studies (e.g.: number of SAE reports, number of particular case) can also performed.

✓ Emergency situations can be noted easily.

✓ Can be used in Inclusion and exclusion criteria selection

✓ Helps in finding Contraindicated medications

DISADVANTAGES OF EMAIL ALERTS

✓ As there is an increased use of email alerts, there might be any chances to miss the alert/notifications.

✓ Email alert has to be short and brief, large files and information cannot be sent.

STEPS TO CREATE AN EMAIL ALERT

✓ The steps to create Email alert e that will trigger an email alert when a specific field is updated are as follows:

1. Set an evaluation criterion

2. Rule criteria (using if logic)

3. Set the automated actions to the criteria

a. Immediate action

b. Time dependent action

  SETTING AN EVALUATION CRITERIA

• Evaluation criteria is a general criterion that should be used as a basis for developing evaluative questions through the full range of evaluations topics and ways of conducting the evaluation.

  SETTING RULE CRITERIA

✓ Rule Criteria is applied to the evaluation criteria. Rules applied to the evaluation criteria can be very general or very specific.

✓ Rule criteria is to be evaluated each time a record is created. If the rule criteria is according to the study , run the rule and email is triggered . Ignore if not met.

✓ This criterion mainly depends on the if- else logic

✓ If/ else statement is a logical and conditional statement that can evaluate the condition and executes the action

  SETTING AN AUTOMATED ACTION

• Immediate action: The action will be triggered immediately

• Time dependent action: one can apply a time factor to trigger the action

✓ COMPOSITION OF EMAIL ALERTS IN CLINICAL TRIAL

✓ From and to address

✓ Subject ID

✓ Study ID

✓ Details of the Study

✓ AE term, start date and stop date

✓ Suspect drug details

✓ Dechallenge and Rechallenge details (if Applicable)

✓ Outcome of the Event

EMAIL ALERTS can be used in

✓ SAE Alerts (SERIOUS ADVERSE EVENT ALERT)

✓  Pregnancy

✓  AESI Alerts (Adverse Events in Special interest Alerts)

SAE Alerts

An AE can be SAE when it falls under following criteria

• Results in death

• Life threatening

• Increased hospitalization

• Causing disability

• Birth defect

• Requires medical interventions/ medically significant

SAE Alerts:

SAE alert is a feature that sends email notifications to the specified recipients when an AE falls under any of the SAE criteria that occur during the study.

• When selected option yes for IS AE AN SAE an email notification will be triggered.

• SAE alerts notify data managers, investigators and other important persons involved in drug safety.

• Days of the event can also be counted and triggered accordingly (time dependent action)

✓ The steps to create a Workflow Rule that will trigger an SAE alert when AE is updated as SAE

1.Set an evaluation criterion: Is AE an SAE?

2.Rule criteria: If AE an SAE, then trigger SAE alert.

3.Setting an Automated action

a) Immediate action: For immediate notifications

b) Time dependent action: can be used to send day wise reminders for the SAE FROM (Study ID) and TO (Group mail, PV and Safety departments)

COMPOSITION OF SAE ALERT

✓    SUBJECT OF SAE ALERT: SAE alert has been triggered (SAE term)

✓     Details of SAE (study and site ID)

✓     SAE start date

✓    SAE end date

✓    Suspect drug details (Start date and stop date)

✓    Severity of SAE

✓    Outcome of SAE

AESI (ADVERSE EVENT SPECIAL INTEREST)

• AESI is an adverse event which might be serious or non- serious and requires further investigations in order to characterize and understand the event.

• Reporting of an AESI is important and more critical aspect to define the study drug.

• The non- serious type of AESI can be precursors for the Serious ones. Thus, it is important to monitor AESI.

• AESI are mentioned in the protocol and explained properly

AESI Alert

• AESI Alert is a feature that sends email notifications to the specified recipients when selected as AESI

ADVANTAGES OF AESI ALERT

✓ Reporting AESI will help in characterizing the safety profile of the drug

✓ AESI are mostly reported in vaccines thus can know the risk- benefit ratio of vaccines

Composition of AESI alert

✓ Subject of AESI: AESI has triggered

✓ Body of email:

✓ study id, subject id

✓ Details of the AESI

✓ Suspect drug details

✓ Outcome of AESI

PREGNANCY ALERT

• Pregnancy alert is a feature that sends email notifications to the specified recipients when a subject is female and is in Pregnancy condition.

• Pregnancy alert can be helpful in avoiding the pregnancy contraindicated drugs

• This alert is triggered when pregnancy is selected as YES

• SUBJECT OF PREGNANCY EMAIL: Pregnancy Alert has created

✓ Body of the mail:

• Subject details

• Pregnancy trimester

• Medication details

ADVANTAGES OF PREGNANCY ALERTS

✓ To avoid contraindicated medications in pregnancy.

✓ To monitor the pregnancy condition on weekly or monthly basis.

REFERENCES

1. https://www.medidata.com/en/clinical-trial-services/medidata-training/rave-email-alerts

2. https://www.alert-software.com/blog/the-advantages-and-disadvantages-of-email

3. https://www.alert-software.com/blog/pros-and-cons-of-text-and-email-alert-systems

4. https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/SAE/

5. SAE Alert Notice Guidance Document

6. https://www.porthosp.nhs.uk › research › docs › sop

7. https://allaboutpharmacovigilance.org/adverse-event-of-special-interest-aesi/

BY

B. AKHILA SAI, Pharm-D Intern, Student at Clinosol.

K. SANJANA, Pharm-D Intern, Student at Clinosol.

Y. ANUSHA, Pharm-D Intern, Student at Clinosol.