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of 16 Effective: 04 August 2019 Version: 1

The Amgen Safety Reporting Portal (ASRP) Supplemental Instructional Guide – External Programs

Administrative notes: This Supplemental Instructional Guide is intended to support the demonstration provided to users from Amgen Safety or your Amgen Manager. Screenshots contained in this Guide may become outdated upon ASRP / Portal enhancements. For current screenshots or additional Portal training, contact [email protected] with your formal request. Acronyms: ASRP: Amgen Safety Reporting Portal; Portal PSP: Patient Support Program IST: Inside Sales Team REMS: Risk Evaluation & Mitigation Strategy 1) Navigating to the ASRP / Portal ASRP Production Environment Link: https://amgensafetyportal.force.com/asrp Notes: All cases entered into the Production environment are submitted with the intent for

processing by Amgen Case Management, Amgen Quality and reporting to Worldwide Health Authorities (as applicable). Test / training cases are not to be submitted via the ASRP Production Environment. If a test / training case or a case is submitted inadvertently or in error, please forward the Amgen Reference ID to [email protected] with details of the incident.

2) Registering for the Portal Users must register for the Portal prior to accessing. Your “Organizational Code” will be provided to you by your Amgen contact and will be in the format:

- PSP format: “PSP-#####” - IST format: “IST-#####” - REMS format: “REM-#####”

Each External Program has a unique Organization Code. If you work on multiple Programs you will be provided multiple Organization Codes.

Step 1: Click “Register” on the Portal main page

Step 2: Click the “+” to add your “Organization Code”.

Step 3: Add your Program specific Organization Code(s) and click “Ok”. If you work on multiple Programs, add additional Organization Codes by clicking the “+” button.


Step 4: Complete the “Registration Form” with your demographic data, complete the captcha requirement and click “Register”.

Note: A unique email address must be utilized for each user. Multiple users cannot register under the same email address.

You must use your company issued email address. Personal email addresses will be deleted upon Portal user maintenance.

Upon registration, the user will receive a “Temporary Password Email” to their registered email

address which provides the initial password for logging into the Portal for the first time.

Step 5: Access the “Temporary Password Email” and follow the instructions (example email below) to log into the Portal for the first time.

Step 6: Change your password as prompted by the Portal upon first time log in. You will be required to re-enter your Program specific Organization Code and click “Submit”.

Format based on Program Type: PSP-#####, IST-#####, REM-#####

As Needed


You will immediately be directed to the “Training Form” upon first log in and password change.

Certifying this “Training Form” does not substitute certification/recertification of Safety Reporting Training as outlined in your Safety Appendix.

Step 7: Download the PDF, Read the Training Form, Certify that you have read and understood the training material and click “Accept”.

You will be directed to the “Submission Form” for the Portal. 3) Accessing the Portal Users must register for the Portal prior to accessing.

Step 1: Utilize the Portal Production Environment Link: https://amgensafetyportal.force.com/asrp in your preferred browser or on an internet capable smart phone/device.

The Portal will work on the following browsers; however, Google Chrome® is the recommended browser:

Step 2: Enter your “Username” (Registered email address), “Password”, and click “Log In”.

Format based on Program Type: PSP-#####, IST-#####, REM-#####


You will be directed to the “Submission Form” of the Portal. 4) Filling out the Submission Form The purpose of this section is to assist in identifying “what” to report in each field. The fields are

relatively self-explanatory. Direct any Submission Form field questions to [email protected] and include the field name and question.

The verbatim is to be reported in all fields. If “Unknown” or “Not Provided”, utilize the “UNK/NP checkbox” and this will count as the response for that field.

The Submission Form is composed of five (5) sections and it is recommended to work from top to bottom.

A red asterisk (*) denotes a mandatory field and entry is required to submit the report. Per your local privacy laws, all applicable fields must be reviewed and completed accordingly, regardless of mandatory indication.

The user can go section to section by clicking on the section title. This will open the section and

display the fields.

Privacy Statement

Privacy Statement: On-screen privacy language is displayed at the top of the portal and intended to be reviewed with the reporter. If the reporter requests further information surrounding Amgen’s privacy practices, click where indicated and read the extended version of the privacy statement to the reporter.


Section 1) “General”

If the user works on one Program, the Organization Code field will default to that Program ID. If the user works on multiple Programs, the appropriate Program ID for the Safety Report must be

selected. Change by using the downward arrow to select the appropriate Program ID applicable for the Safety Report.

Follow-up checkbox: If the report is a follow-up or data correction to a previously submitted case,

check the box. Checking the box will open the “Prior Master Case Number” field. If a follow-up or data correction, provide the prior Master Case Number which will be updated.

If the case is an initial report, no action is required by the user. A follow-up is defined as new information to a previously submitted report. Notes: Use of the “Follow-up” and “Prior Master Case Number” fields will retrieve previously submitted case

information allowing quicker data entry. Using this feature requires the Portal user to update the case/provide new case details only (example):

This feature is only accessible with Master Case ID Numbers associated with the original

Organization Code / Program ID. If the prior Master Case ID number entered is not associated with the user’s Organization Code, an error message will appear (example):


This feature is only accessible with submissions post 04 August 2019. Submissions prior to 04 August 2019 will not retrieve case data from the system. If the prior Master Case ID number entered was submitted prior to 04 August 2019, an error message will appear.

If a user needs to notate an Amgen Reference ID number from a case prior to 04 August 2019, add the previous Amgen Reference ID number to the Case Description when detailing the report.

Created By: The user’s registered email address will display. No action is required.

Country: Select the “Country” of event occurrence. The system will default to the user’s profile

registered country. Change by using the downward arrow (as applicable).

Date of Awareness: The date the vendor initially received the report. To populate, click on the

calendar icon. Adjust the year and month as needed, then, click on the day. Verify the intended entry is accurate.

Vendor Reference ID: The vendor, case specific, unique “internal” reference ID. This ID number is

how the vendor would search for the case in their system. It is commonly referred to as a “patient ID” or “CRM ID”. Discuss with your manager which case specific unique “internal” ID is applicable to populate in this field. This field should not be populated with N/A, similar, or with your Program ID.

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Reported by HCP: Was the case reported by a Health Care Professional (yes or no)?

- If marked “Yes”, Consent to Contact Patient will default “No”.


- If marked “Yes”, HCP details become mandatory for entry (HCP First/Last Name).

Consent to Contact HCP: Is there consent to contact the HCP (yes or no)? - If marked “Yes”, the user must provide a method of contact. Methods: Complete Telephone Number

or Complete Email Address or Complete Mailing Address.

Consent to Contact Patient: Is there consent to contact the Patient (yes of no)? - If marked “Yes”, the user must provide a method of contact. Methods: Complete Telephone Number

or Complete Email Address or Complete Mailing Address. Consent to Contact Complainant/Reporter: Is there consent to contact the individual reporting the

Safety Event (yes or no)?

The “Product” dropdown will be Program specific. If the Program only has one Amgen product

involved, the dropdown will only list that product. If the Program has multiple Amgen products involved, that simplified list of products will display. Change by using the downward arrow to select the Amgen product involved in the report. If more than one Amgen product is reported, select the primary Amgen product in this dropdown and report additional Amgen product(s) in the Event Description. If an Amgen product is reported that is not supported by the Program, select an available product in the dropdown and clearly document the reported product and Safety Report details in the case description.

Delivery Method: This is the product pharmaceutical form/product presentation. Select the

appropriate product “Delivery Method” (as applicable). Change by using the downward arrow to select the delivery method (as applicable). The dropdown will populate based on the product selected. If unknown or not provided, click the UNK/NP checkbox

Lot/Batch Numbers: Free text the reported lot/batch numbers of the Amgen Product used (as

applicable). If unknown or not provided, click the UNK/NP checkbox. Selecting UNK/NP will make available the “Reason for Missing Lot No.” dropdown.


Reason for Missing Lot No.: Dropdown that becomes available when selecting UNK/NP as the “Lot/Batch Numbers” entry. Change by using the downward arrow to select the reason for missing lot number. If the Lot/Batch number was provided, this dropdown will not become active.

Device Serial Number(s): Field becomes available when an Amgen Combination product is selected.

Examples include: Autotouch, OnPro and Pushtronex/Amgen Mini-Doser (AMD). If a product selected is not a combination product, no action is required.

Indication/Diagnosis/ICD: Free text the reported indication/diagnosis/ICD for the Amgen Product used

(as applicable). If unknown or not provided, click the UNK/NP checkbox.

Dose/Frequency: Free text the reported dose/frequency of the Amgen Product used (as applicable). If

unknown or not provided, click the UNK/NP checkbox.

Upload Document: If the program has source documents, they must be reported to Amgen with the

report. Click “Upload Document” and attach source documents as applicable. If no source documents are associated with the report, no action is required by the user. Best practice: Uploading source documents in PDF format and only source documents relating to the Safety Report.

Section 2) “Patient Details” Although all fields are not marked with a red asterisk (*) denoting mandatory, if the details are

provided to the user and there is no restriction per local privacy law to transmit to Amgen, the details must be provided to Amgen in the appropriate field.

Correct spelling and accuracy of patient details, such as the patient’s name, will reduce the amount of duplicate reporting. Confirm the correct, full spelling of all patient demographics.

If Consent to Contact the Patient is marked “Yes”, the user must provide a method of contact. Methods: Complete Telephone Number or Complete Email Address or Complete Mailing Address.

First Name: Enter the reported “First Name” or “First Initial” of the patient (as applicable and based on

consent). If unknown or not provided, click the UNK/NP checkbox.


Last Name: Enter the reported “Last Name” or “Last Initial” of the patient (as applicable and based on


Primary Phone Number: Enter the reported “Phone Number” of the patient (as applicable and based

on consent). If unknown or not provided, no action is required by the user.

Email: Enter the reported “Email” of the patient (as applicable and based on consent). If unknown or

not provided, no action is required by the user.

Address: Enter the reported “Street Address” of the patient (as applicable and based on consent). If

unknown or not provided, no action is required by the user. City: Enter the reported “City” of the patient (as applicable and based on consent). If unknown or not

provided, no action is required by the user. State/Province: Enter the reported “State/Province” of the patient (as applicable and based on

consent). If unknown or not provided, no action is required by the user. Country: Select the “Country” of the patient (as applicable). The system will default the country to the

user’s profile registered country. Change by using the downward arrow to select a different country (as applicable). If unknown or not provided, no action is required by the user.

Postal Code: Enter the reported “Postal Code” of the patient (as applicable and based on consent). If unknown or not provided, no action is required by the user.


Date of Birth: Enter the reported “Date of Birth” of the patient (as applicable and based on consent). If

unknown or not provided, click the UNK/NP checkbox. To populate, click on the calendar icon. Adjust the year and month as needed, then, click on the day. Verify the intended entry is accurate.

Age: Enter the reported “Age” of the patient (as applicable and based on consent). If unknown or not

provided, click the UNK/NP checkbox. Age Unit: If the “Age” field is populated, the user will have to select the age unit of the patient. The

system will default to the selection: “Year”. Change by using the downward arrow to select a different response (as applicable).

The “Age” and “Date of Birth” are independent fields in the system. A user can enter one or both as provided by the reporter. Validate all intended entries. If the “Age” and “Date of Birth” are marked UNK/NP, the “Age group” will become available

Age group: If the “Age” and “Date of Birth” are checked UNK/NP, the “Age group” dropdown will

become available. Change by using the downward arrow. If unknown or not/provided, select “UNK/NP”.

Gender: Select the reported “Gender” of the patient (as applicable and based on consent). Change

by using the downward arrow to select the gender (as applicable). If unknown or not provided, select “Not Specified” from the dropdown.

Section 3) “HCP Details”

HCP is any Health Care Professional related to the report. The reporter can either be a HCP or a

non-HCP reporter (example: patient/caregiver) and can provide HCP details.


Although all fields are not marked with a red asterisk (*) denoting mandatory, if the details are provided to the user and there is no restriction per local privacy law to transmit to Amgen, the details must be provided to Amgen in the appropriate field.

If reported by a HCP, the user must provide the HCP’s First and Last name or issue. If Consent to Contact the HCP is marked “Yes”, the user must provide a method of contact. Methods:

Complete Telephone Number or Complete Email Address or Complete Mailing Address.

First Name: Enter the reported “First Name” or “First Initial” of the HCP (as applicable and based on


Last Name: Enter the reported “Last Name” or “Last Initial” of the HCP (as applicable and based on


HCP Type: Select the reported “HCP Type” of the HCP (as applicable and based on consent).

Change by using the downward arrow to select the HCP type (as applicable). If unknown or not provided, no action is required by the user.

Email: Enter the reported “Email” of the HCP (as applicable and based on consent). If unknown or not

provided, no action is required by the user.

Phone Number: Enter the reported “Phone Number” of the HCP (as applicable and based on

consent). If unknown or not provided, no action is required by the user. Fax Number: Enter the reported “Fax Number” of the HCP (as applicable and based on consent). If

unknown or not provided, no action is required by the user.


Address: Enter the reported “Street Address” of the HCP (as applicable and based on consent). If

unknown or not provided, no action is required by the user. City: Enter the reported “City” of the HCP (as applicable and based on consent). If unknown or not

provided, no action is required by the user. State/Province: Enter the reported “State/Province” of the HCP (as applicable and based on consent).

If unknown or not provided, no action is required by the user. Country: Select the “Country” of the HCP (as applicable). The system will default the country to your

profile registered country. Change by using the downward arrow to select a different country (as applicable). If unknown or not provided, no action is required by the user.

Postal Code: Enter the reported “Postal Code” of the HCP (as applicable and based on consent). If unknown or not provided, no action is required by the user.

Associated Institution Name: Enter the reported “Institution Name” of the HCP (as applicable and based on consent). If unknown or not provided, no action is required by the user.

Section 4) “Adverse Event / Other Safety Finding”

All details regarding a reporting Adverse Event (AE) and/or Other Safety Finding (OSF) go in this

section. Describe all details regarding the report. Tell the “complete story”. Provide context of the event occurrence – the Who, What, When, Where, Why and How. Details that do not have a distinct field (examples include medical history or concomitant medications)

are to be entered here. If there are no AE or OSF details: Leave the “Description” box blank.

This field will self-expand and condense. The user can manually adjust by dragging the bottom right

corner with the cursor. More report details assist in the processing and handling of the report.


Select One: If your program has an uploaded AE/OSF template, it will be visible by clicking the

downward arrow and selecting the template (as applicable). If your program does not use a template, no “Select One” will display.

Section 5) “Product Complaint”

All details regarding a reporting Product Complaint (PC) go in this section. Describe all details regarding the report. Tell the “complete story”. Provide context of the event occurrence – the Who, What, When, Where, Why and How. If there are no PC details: Leave the “Description” box blank.

This field will self-expand and condense. The user can manually adjust by dragging the bottom right

corner with the cursor. More report details assist in the processing and handling of the report.

Select One: If your program has an uploaded PC template, it will be visible by clicking the downward

arrow and selecting the template (as applicable). If your program does not use a template, no “Select One” will display.

Product Available for Return: This dropdown details the availability of the product for return to Amgen.

The system will default to the selection: “No”. Change by using the downward arrow to select a different response (as applicable).

Replacement Request: This dropdown field is if the reporter specifically requests to have a product

replacement provided. The system will default to the selection: “No”. Change by using the downward arrow to select a different response (as applicable).


Date of Birth: This Date of Birth field is required when a Replacement is requested. The system will

transition the Patient Date of Birth to this field. If no Date of Birth is provided in the Patient Section, the system will generate an error message (below).

5) Previewing and Submitting the Safety Report The user must populate all the applicable fields and mandatory fields based on the reported.

Step 1) Click “Preview”

If the user fails to populate a mandatory field, an error message will populate providing direction to

the user. Example:

Step 2) Review the “Preview” view

The user must quality check all the entries to ensure accuracy of the report. If the user finds an inaccuracy, click “EDIT”, make the necessary changes and repeat Step 1) Click

“Preview”.

Step 3) Click “Submit”

The system will process the submission and immediately provide an Amgen Reference Number / confirmation number at the top of the screen.

The Amgen Reference Number will be emailed to the user.


The Amgen Reference Number will be emailed in a report to the program centralized email address. Retain the Amgen Reference Number based on your internal document retention policies. The Amgen Reference Number must be provided to Amgen during reconciliation.

Step 4) Receive and Retain Amgen Reference Number Top of Portal post submission example:

Email to user example:

6) Additional Portal Details The Portal is available for use in multiple languages.

Language: To use the Portal in an alternate language, click the downward arrow and select the

preferred available language. The Portal defaults to English. If English can be used, no action is required by the user.

The Portal has a link for “Privacy & Terms”.

Privacy & Terms: Click and a pop-up will link the user to the Amgen Privacy and Terms public

webpage.

The Portal has a method to contact Amgen for technological support.


Contact Portal Administrator: Click to reach Amgen Technical Support. Fill out the form and Submit.

To log out of the Portal, click “Log Off”. Logging off deletes any un-submitted information.

The Portal has a toolbar.

Submission Form: Clicking refreshes the current submission form. Note: un-submitted data is cleared and lost. If on the profile page, clicking takes the user to the submission form.

Profile: Click to view your profile and edit as required. Reminder: Save your intended changes. Training: Click to pop up the embedded training materials. Refer to the Safety Reporting Training for

provided to you by Amgen Safety. Portal users can reset their password.

The user will receive a temporary password via email. Follow the instructions to set a new password.

TIPS: When using the Portal on a mobile device, it is recommended to operate in landscape mode. If you do not receive an Amgen Reference ID or error message upon submission, the submission was

not successful. Report the incident and attempt to submit the Safety Report once more.

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