New eSAE Reporting Process
Training for Investigators
Trial: xxxx.xx
Date of Training:
Training Objectives
 Understanding the new eSAE reporting process
 Understanding the Investigator/site role within the eSAE reporting
process
SAE Reporting for Investigators (eSAE process)
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Agenda
 Provide overview of the RAPID project
 Review of the eSAE workflow and responsibilities
 Review eSAE processes:
•
•
•
•
Entering the eSAE case form
Query
Case deletion
DEDP (Drug Exposure During Pregnancy)
 Emergency unblinding
 Contingency plan
 Contact information
 Training
 Review questions
SAE Reporting for Investigators (eSAE process)
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Overview of RAPID
(RDC ARISg Process Interface for Drug
Development)
Scope of the RAPID Project:
 Implement one system for entry and reporting of Serious Adverse
Events (SAEs) in clinical trials by using existing information sources
O*C/RDC and ARISg.
Advantages:
 Avoid inconsistencies among the two information sources (eCRF and
paper SAE form), by reducing information source to one
• New eSAE form added to RDC. No paper SAE form will be used.
• Reconciliation no longer needed between Drug Safety and Clinical
databases.
 Allow for a well documented and auditable query process.
 Decrease duplication of processes (Coding of data performed only
once).
SAE Reporting for Investigators (eSAE process)
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Information flow from RDC to
ARISg
RDC Oracle
Database
ARISg Database
Interface transfer
Coding
completion
-Inv . enters data into RDC
-Inv. creates an eSAE case
form in RDC
-Inv. approves information in
RDC
SAE Reporting for Investigators (eSAE process)
Queries
entered into
RDC
-Receives RDC
information directly into
designated fields of the
data entry workflow
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SAE Reporting in RDC Clinical Trials
eSAE CASE FORM MUST BE APPROVED IN A TIMELY MANNER
 Approval of eSAE information in RDC (both initial and follow-up) should
adhere to current BI timelines for reporting of SAEs (within 24 hours or
the next business day whichever is shorter)
 The information provided should capture all relevant SAE information to
allow for adequate assessment of the case in order to fulfill regulatory
reporting requirements
SAE Reporting for Investigators (eSAE process)
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CRA and CML Responsibilities
 CRA is responsible to verify that the eSAE form is
• complete and correctly entered in RDC
• approved by the investigator in RDC and each update is to be reapproved
* please note that updates to the eSAE case form
will not transfer to ARISg unless they are approved
• CML is responsible to follow-up on outstanding queries upon
notification from Drug Safety
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Process for New eSAE Case
 Enter AE CRF for each event that is part of case for the patient (serious
and non-serious, if applicable)
 Assure that entry of demographics, baseline conditions and concomitant
therapies is up-to-date for this patient
 Create a new eSAE case form
 Investigator reviews form contents and approves eSAE case form as
soon as all the information is complete
 Update SAE case information as necessary and obtain re-approval by
investigator
SAE Reporting for Investigators (eSAE process)
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Entering the eSAE Case Form in RDC
 Link associated AE CRFs
 Complete case-specific
information on eSAE case form
 Add onset date for Baseline
Conditions
 Link relevant CT CRFs
SAE Reporting for Investigators (eSAE process)
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Entering the eSAE Case Form in RDC
(cont’d.)
 Add any additional medications
not on a CT CRF
 Review derived AE information
SAE Reporting for Investigators (eSAE process)
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Query Process in RDC
 All queries are posted in RDC
 For urgent queries sites may receive an e-mail and/or phone call from
Drug Safety requiring further clarification in addition to the posting in
RDC. (see example query below)
• “An urgent query is present in RDC regarding data entered for Trial #,
Site #, Patient #, CRF Name: Please access RDC to review this
urgent query and make the necessary updates.”
 All responses to queries must be entered in RDC and should not be sent
via e-mail or answered by phone to Drug Safety.
 When responding to discrepancies please return the discrepancy to the
originator before re approving the form. This means that after all
changes have been made and all discrepancies have been addressed
the last step is to approve the form.
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Queries from Drug Safety
Drug Safety queries can be entered on the eSAE case form and also on
related forms (i.e., AE, CT Demographics and Baseline Conditions).
These queries will be identified as having been entered into RDC by Drug
Safety personnel.
There is a new Action added “Send to Drug Safety”. Any queries from
Drug Safety must have responses returned to them.
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Deletion of eSAE Case Form
New deletion selection criteria are available in RDC for SAEs
 They have been added to the bottom of the standard drop down
list
SAE Reporting for Investigators (eSAE process)
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Deletion of eSAE Case Form (cont’d.)
 The investigator should provide any additional details regarding the
deletion in the text box field.
 If the reason for deletion is duplicate case, please delete the later case
and keep the earlier case in the database.
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Reporting Drug Exposure during
Pregnancy
 Drug Exposure During Pregnancy (DEDP) reports will remain the same
using the paper Pregnancy Monitoring form for clinical trials.
 When filling out the Pregnancy Monitoring form for clinical trials be sure
to only include the study drug exposure information.
 File the DEDP form in the ISF.
 The complete Pregnancy Monitoring form must be faxed to the local
CML/CSO immediately.
 Do not include any SAE information. All SAEs must be entered in
RDC via the eSAE case form.
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Emergency Unblinding
 If a patient needs to be unblinded for emergency reasons at site
level then the actual unblinded treatment must be documented on
the eSAE case form as follows:
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Contingency Plan
In case of system unavailability for more than 24 hours this contingency
plan must be followed:
 The paper SAE form located in the ISF must be filled out. The
instructions for form completion can be found in the ISF.
 The complete paper SAE form must be faxed to the local CML/CSO
immediately. The centralized process is to be followed.
As soon as the system is available again, the information must be
entered into RDC.
After removal of access to RDC at the end of the trial
The complete paper SAE form must be faxed to the local CML/CSO as
described above.
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Contact Information
 For RDC system related questions/technical difficulties: Contact
RDC help desk. See the flyer: RDC Onsite: Getting RDC
Assistance
 For SAE related or protocol specific questions: Contact your
responsible CML or designee.
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Training for eSAE Case Form
This presentation is available also on the WBT site:
There is a special chapter in the WBT(see next slide) describing the entry
of the eSAE form in RDC.
A PDF of this chapter is available there for printing.
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Web based training (WBT) for eSAE Case
Form
Sites that have completed the
RDC training (for another trial)
are required to complete the
Electronic SAE Reporting
Process chapter.
There is a certificate that must be
printed, signed and filed locally
that is only for this new chapter.
There is still the usual training
confirmation in RDC for RDC
training.
http://bi20.luvit.se/RDConsite
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Questions and Answers
1. Are sites required to print out the patient data report for the SAE case
form?
No . However, the form can be printed following the instructions in the
WBT
2. Should responses to urgent queries be sent to Drug Safety via e-mail?
No – all responses to queries must be entered into RDC
3. Will DEDP cases be entered in RDC?
No – the DEDP cases will be reported using the paper Pregnancy
Monitoring Form
and faxed to the local CML/CSO
4. Is approval needed for the initial eSAE case form and all updates?
SAE Reporting
(eSAE process)
Yesfor–Investigators
the Investigator
must approve both initial and all updates in
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Questions?
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