Temple Adverse Event Reporting System
1. What is Temple’s Adverse Event Reporting System?
The Temple Adverse Events Reporting System is an electronic web-based serious adverse
events reporting, updating and management system. The goal of the system is to simplify
the reporting of Serious Adverse Events and maintain an electronic file of all SAE’s
reported to the IRB. The system operates with security features and all users will have an
individual userID and Password for access to their clinical trials.
The Principal Investigator is responsible for reporting all serious adverse events to the IRB
for both Temple and Non-Temple participants who experience an SAE. The Principal
Investigator at the start of the clinical trial or during the course of the trial will be able to
designate qualified staff that will be able to access the system to report events.
2. How am I granted access to use Temple’s Adverse Event Reporting System?
The Principal Investigator responsible for the conduct of the clinical trial will designate
qualified staff to be allowed access to the system for each individual study. The Principal
Investigator must notify the IRB of these staff members and access will be granted by the
IRB Manager following the successful completion of the following steps.
 Completion of Human Subjects Training as required by the IRB
 The Principal Investigator has informed the IRB of staff members who need access
to the system.
 Completion of training on the web system
3. How Do I Access the Temple Adverse Event Reporting System web site?
Once you have been added to the Temple Adverse Event reporting system by the IRB
manager you access the system at the following Web-Address.
Web-Site address: https://atlas.ocis.temple.edu/adverse_events
AccessNet ID: This is your Temple e-mail address User ID Name. This is not the full email address this is just the UserName on the Account.
Password: This is your Temple e-mail address password. If you cannot remember your
password you need to call the computer services help desk. DO NOT share your password
with others for the purpose of adverse events reporting.
 You can access the AccessNet Account Website
 Call the Computer Services Help Desk at 215 204-8000
4. How Do I Report, Update or View the Serious Adverse Events related to my study?
When you log onto the web site you will be provided a table of current protocols that you have
been provided access to by the principal investigator.
Protocol Title
A double blind
trial…
IRB Number
1111
Sponsor
Pharmaceutical
Principal Investigator
John Doe
 Protocol Title: The full title of the protocol as indicated on the IRB submission packet
 IRB Number: The four digit IRB Number assigned by the IRB staff
 Sponsor: The sponsor of the protocol-Pharmaceuticals, Biotechnology, Government
Agency, Department Funds
 Principal Investigator: The principal investigator listed on the IRB application page.
To enter a New SAE to be reported to the IRB
1. Click on the title of the protocol listed on the page.
2. This will take you to an options screen that will allow you to perform the following
activities.
 Create a New Adverse Event Record
 Find an Adverse Event Record
 List All Adverse Events Record
 Adverse Event Report in Non-Temple subjects
3.
Click on the Create A New Serious Adverse Event Record
 This will create a Serious Adverse Event Reporting Form for the study staff to
complete
 The study staff will be responsible for completion, printing, and paper
submission to the IRB for the Serious Adverse Events Committee review.
 Currently, the submission process will remain the same – consisting of paper,
including the printed event and supporting documents.
Completion of the Serious Adverse Events Form
 The Serious Adverse Events Form will be populated for the reporting of the Event.
 The top of the page will be populated to include the following information:
Protocol Identification Information listed at the top of the page:
Protocol Title
IRB Protocol #
A double blind trial
1111
Date Created
Month/Day/ Year
Sponsor:
Principal
Investigator
Created By:
Computer Services
Name
Name
 The Serious Adverse Event Form must then be completed by a study staff member who has
an authorized UserID and Password and who is logged into the system under their individual
UserID and password. The sharing of UserID and password is prohibited.
Serious Adverse Event Reporting Form Information
TEMPLE ENROLLED SUBJECTS
Questions to be addressed when reporting a serious/adverse event during
participation in a clinical trial
*-Indicates a required field for subjects enrolled at Temple.
 *Question #1: Is the patient currently enrolled in a study at Temple? This indicates if
the subject has signed an informed consent for participation in a clinical trial under the
auspices of the Temple Institutional Review Board.
 YES: Subject is enrolled or is within 30 days following completion of the clinical
trial.
 NO: This would be a Serious Adverse Event reported to the investigative site
regarding the investigational medication. These reports may be generated by the
study sponsor and may or may not be from the clinical trial you are performing,
however is the same study medication.
 *Question #2: Study Status: This represents the IRB status of the protocol at Temple.
 Protocol Pending Approval-The initial IRB submission is complete, however the
principal investigator has not received the approval certificate and stamped informed
consent.
 Open-The study has received IRB approval certificate and stamped informed
consent and subjects are being recruited.
 Closed to enrollment- The clinical trial is closed to subject recruitment, however
subjects may still be continuing on study medication or study procedures. The IRB
has not been informed that the study is completed.
 Closed- The study is complete and the IRB has been informed that the study is
closed.
 *Question #3: Serious? Consistent with Federal Guideline on reporting Serious Adverse
Events. Please see question #4
 YES: If the adverse event meets the definition of a Serious Adverse Event as
indicated in questions #4
 NO: If the event does not meet the definition of a Serious Adverse Event, but is
being reported to the IRB.
 *Questions #4: Serious Event Type: (Only one selection should be entered. The most
significant event should be reported)
 Congenital Anomaly
 Death
 Disability
 Hospitalization
 Life Threatening
 Required Intervention
 Prolonged Hospitalization
 *Question #5: PI’s Assessment of Relation: The principal investigator is responsible for
determining the relation of the adverse event to the investigational medication, device, or
study procedure.
o Related
o Likely
o Possibly
o Unlikely
o Unrelated
 Question #6: Sponsor Assessment of Relation: If after the Serious Adverse Event is
reported to the sponsor the sponsor may make an assessment regarding the event. Please
complete this question if the information is accessible. This is not a required field. (This
question is typically more applicable to non-temple subjects SAE reports and is not a
required field for Temple SAE reports.)
o Related
o Likely
o Possibly
o Unlikely
o Unrelated
 *Question #7: Status of AE -The status of the subject’s experience in regards to the adverse
event at the time it is reported to the IRB?
o Intermittent-A condition that subsides and is again exacerbated.
o Ongoing- The adverse event is ongoing such as a hospitalized
o Resolved- The adverse event is no longer occurring
 *Question #8: Event Description: Text must be entered into this box to describe the
adverse event. It is recommended that the event description be limited to the diagnosis or
signs and symptoms experienced.
 *Question #9: Event Severity: The principal investigator is responsible for determining
the severity of the serious adverse event. The event severity is not necessarily severe for all
serious adverse events.
o Mild
o Moderate
o Severe
 *Question #10: Does the Adverse Event require modification to the informed
consent?: The principal investigator or sponsor need to asses if a change to the informed
consent is required due to the adverse event. If a change is not necessary, please select the
correct response. If a change is needed the updated informed consent must be submitted
with the adverse event report for review by the IRB. The IRB may request an updated
informed consent following review.
o YES
o No, Currently Listed
o No, Not needed
 *Question #11: Does the Adverse Event require modification to the investigational
brochure? The sponsor will provide guidance if an amended investigator brochure has
been produced. If there is an updated investigator brochure please provide a copy to the
IRB.
o YES
o No, Currently Listed
o No, Not needed
 *Question #12: Race-The selection of race should be consistent with the demographic
selection when a subject is enrolled into a clinical trial.
o American Indian/Alaskan Native
o Asian
o Hawaiian/Pacific Islander
o Black/African American
o Hispanic
o White Caucasian
o Unknown
o Other
 Question #13: Subject ID Number: The subject identification number should be provided.
 *Question #14: Subject Study Status: The subjects study status must be reported
o Pre-Screening: Subject has signed informed consent, however study specific
procedures have not started
o Screening: Subject has signed informed consent and study specific procedures have
started. The subject has not started taking investigational medication or device
implantation.
o Failed Screening: Subject does not meet the eligibility criteria and is not
participating in the clinical trial; however the subject has reported an event that in the
investigators judgment should be reported to the IRB.
o In Treatment: Subject is receiving protocol treatment, protocol procedure or
protocol medical device – and is continuing in the study.
o Patient Dropped: Subject was randomized into the clinical trial, however was
dropped from the study either due to this AE or other circumstances.
o Patient Withdrew: Subject withdrew consent from the study and in no longer
participating in the clinical trial. The subject may withdraw consent due to this
adverse event.
o Completed: Subject has completed the clinical trial, however it is mandated that all
serious adverse events be reported up to 30 following subject completion in the
study.
 *Question #15:
o Age in Years
 *Question #16 Gender:
o Male
o Female
o Unknown
OR
Date of Birth (mm/dd/yyyy):
 Question #17: Weight in units: (LBS or KG’s)
 *Question #18: Event Date: This is the date of onset of the adverse event in respect the
subject experience. This date is not the date that the investigative staff is informed of the
serious adverse event.
 Question #19: Date Reported to Sponsor: Please provide the date that the site informed
the sponsor of the serious adverse event. This provides assurance to the IRB that the report
is being reported to the sponsor.
 Question #20: IRB Report Date- The report date is automatically generated when the
documents is opened to be prepared, please ensure the date is correct.
 *Question #21: Report Type: This is the status of this adverse event report. Please submit
only one initial report followed by follow-up reports.
o Initial- First report to the IRB
o Follow-Up- The Adverse event has been reported to the IRB, however additional
information has become available and is being sent
o Final- This is the last information the site has to report to the IRB and additional
information should not be expected unless requested.
 *Question #22: This Adverse Event was related to: Select one or more options that
apply to the relation of the adverse event:
o Study Drug: If the adverse event occurred due to the medications required by the
protocol. This includes investigational medications or FDA approved medications
under investigation for the study.
o Study Device: If the adverse event occurred due to the study devices (s) required by
the protocol. This includes investigational medical devices or FDA approved
devices under investigation for the study.
o Study Procedure: If an adverse event is related to a study specific procedure
required by the protocol. This includes routine procedures that are required by the
protocol.
o Other: If the adverse event is unrelated to any of the selections above. An example
would be if a subject is hospitalized for an injury that was unrelated to study
medication or procedures.
 Question #23: Complete Event Description: Please include a narrative that describes the
adverse event and the events that took place regarding the adverse event. This description
allows a comprehensive report of the event to describe the event to the IRB. Information
within this box may include detailed reports by the subject regarding circumstances of the
event or treatment that was provided to ensure the safety of the research participant.
 Question #24: Significant Laboratory/Test Findings: The laboratory finding must be
included if available. This information allows the IRB to review laboratory reports with the
adverse event to determine any correlation. This field will also allow for reporting multiple
laboratory findings to follow trends. For example is a subjects ALT is being followed for a
couple of days each report should be listed in the report.
 Question #25: Significant Medical History: Please include medical history information
regarding the subject that may be pertinent to the adverse event.
To complete the report you must enter the continue button at the bottom of the
page. This report cannot be saved and information altered at a later date. A
follow up report should be submitted.
Cancel
vs.
Continue
Serious Adverse Event Reporting Form Information
TEMPLE ENROLLED SUBJECTS
ADDITIONAL INFORMATION
The additional information is required depending on the response to
*Question #22: This Adverse Event was related to:
 Study Drug: Study Drug Information
 Study Device: Device Information
 Study Procedure: Procedure Information
 Other: a full description of the event should be present in the previous box identified as
Complete Event Description
Study Drug Additional Information:
 *Generic Name/Compound Number: This is a plan text field. Enter the common name of
the drug such as acetaminophen instead of Tylenol. It the drug is known by a compound
number (no name assigned to the compound) list this number – which may be alpha or
numeric or a combination of both.
 *Pharmacological Classification: This is a plan text field. Enter the mode of action or
effect of the drug or compound such as for urokinase the action is thrombolysis.
 *Study Design: Using the pull down menu, select the appropriate response based on the
study design. Available selections are:
o Open Label- both the participant and the study staff know which treatment was
assigned
o Single Blind- only the study staff knows which treatment was assigned
o Double-Blind- neither the participant nor the study staff know which treatment was
assigned
 Was the study unblinded?
o Yes- The study blind was broken; if yes you will be prompted to identify in a plain
text field the treatment regimen to which the participant was assigned per protocol.
(*this is now a required field)
o No-the study blind was not broken
 Dose: This is a plan text field in which the dose per protocol will be entered. Please be
specific and describe the dose as per protocol
 Frequency: This is a plan text field in which the per protocol scheme of delivery of the
dose is described. Please be specific and describe the frequency as per protocol.
 Route: This is a plan test field in which the protocol method of delivery of the dose is
described. Please be specific and describe the route as per protocol.
 Therapy Dates or Duration: This is a plan text field in which the protocol duration of
treatment is described. This date or duration should be expressed as the length of time the
treatment was given up to and including when the Adverse Event was noted or reported.
This may be based on doses, days, or volume. Please be specific and describe the
dates/duration based on the per protocol plan of treatment.
 Drug Lot No.: This is a plan text field in which the manufactures drug lot number is to be
entered. This may be in alpha and/or numeric form. This will be available from the
Investigational Pharmacy Files for drug stored and dispensed in the Investigational
Pharmacy or on the drug container itself as stored and dispensed in a treatment/investigator
clinic.
 Exp. Date (mm/dd/yyyy): This is a plan test field in which the identified expiration date of
the particular drug or lot is to be entered. Refer to the Drug Lot No. information above for
where to gather this information. Please note that the date is expressed as a 2-digit month, a
2-digit day and a 4-digit year – use leading 0s where necessary.
 Reappeared After Reintroduction:
Using the pull down menu select the appropriate response: Available selections are:
o Yes- The event appeared upon re-introduction of the therapy
o No- The event did not appear upon re-introduction of the therapy
o N/A- Not applicable, there was no dechallenge/rechallenge performed. This is when
a drug or therapy is withheld and the Adverse Event resolves and the drug or therapy
is re-introduced and the effect is measured (appearance of the adverse event or the
adverse event is has not reoccurred).
 NDC No.: This is a number associated with a drug listed in the National Drug Code
Directory. This is a plan text field in which the NDC No. will be entered. Each drug
product listed under Section 510 of the Federal Food, Drug, and Cosmetic Act is assigned a
unique 10-digit, 3-segment number. This number, known as the National Drug Code (NDC),
identifies the labeler/vendor, product, and package size. Should this number be necessary in
an Adverse Events Report and is not available from the Sponsor/Investigators Brochure,
assistance will be provided in gathering the number.
 Concomitant Medications: This is a plan text field in which concomitant medications
administered to the participant either for the treatment of the adverse event or associated
with the adverse event are to be described. Where available include the dose, frequency and
history of administration.
If you selected the Device Information box, you will be requested to provide information
regarding the Study Drug. Items marked with an * are required fields which must be filled
in at the time of the initial adverse event report. Information regarding the Implanted Date
should be provided if applicable, i.e. a device was implanted and associated with the adverse
event.
Study Procedure Additional Information:
 *Device Manufacturer Name
 *Type Of Device:
 *Description of Device This is a plan text field. Enter a description of the device in
sufficient detail for understanding the size, shape, material, function, etc.
 Implantable Date, if applicable if an implantable use utilized per protocol, enter the date
implanted. This is a plan test field; the date is expressed as a 2-digit month, a 2-digit day
and a 4-digit year – use leading 0s where necessary.
Study Procedure Additional Information:
 *Procedure This is a plan text field. Please enter the procedure information in sufficient
detain to describe what was done and what the relationship to the Adverse Event.
 *Routine or Experimental Indication if the procedure as described was per protocol (part
of the research plan) or routine (part of routine care for the participant condition).