Note:
The group access feature is currently available only to users reporting
on "Marketed human drug and therapeutic biologics, and cosmetics," i.e., for
companies registered with the FDA Center for Drug Evaluation and Research
(CDER).
The Group Access feature in the Safety Reporting Portal allows organizations to create an organizational group access to submissions and reports.
Organizations registered with regulatory authorities for one or more regulated products must be validated and approved by FDA before group access is permitted. Once FDA has validated and approved the group access request, a Group will be created in the Safety Reporting Portal. This includes CDER Group Access.
Members can report on adverse events on behalf of the company or group to which they belong. There are two types of members: group lead and normal group members.
The Group Lead is the sender of submissions and can submit reports on behalf of the organization.
The Group Lead has full access to all Draft Reports and can create, read (view), update, and delete drafts—both initial or follow-ups.
The Group Lead has full access to all Submitted Reports from the group, and can read (view, view pdf) submitted reports and create follow-ups.
The Group Lead can search submitted reports by date and/or ICSR number.
The Group Lead can view but cannot change the list of group members and the list of registered products, active ingredients and drug authorization numbers.
There is one group lead per group.
Group members have full access to all Submitted Reports, but can access only his/her own Draft Reports.
Group members can submit reports on behalf of their organization.
Group Members can view a list of their draft reports and can create, read (view), update, and delete initial or follow-up drafts that belong to them.
Group members have full access to all Submitted Reports from the group (including the Group Lead), and can read (view, view pdf) submitted reports and create follow-ups.
Group members can view but cannot change the list of group members and the list of registered products, active ingredients and drug authorization numbers.
To get information on the group, members can click on My Group in the User Home page.
The Group Page is available when the user clicks the My Group option in the left sidebar.
The Group Page displays Group Lead user details in read-only format, the Group Members table (read-only), and the Products table (read only).
Before a pharmaceutical company can report an adverse event report on Marketed human drug and therapeutic biologics, and cosmetics, the company must register to SRP by creating a group, adding designated group lead and group members and listing the products that will be used as primary suspect product in future adverse event reports.
To create a group or change its characteristics (add group user, delete group user, register products), you must complete a CDER SPHR User Registration form.
The form is available at the FDA Center for Drug Evaluation and Research (CDER) (email: FAERSESUB@fda.hhs.gov).
The following procedure must be followed to ensure a successful registration to SRP:
Email CDER (email: FAERSESUB@fda.hhs.gov) to request the registration form.
Fill the form completely and as accurately as possible.
Send the form back to CDER (email: FAERSESUB@fda.hhs.gov).
After the information in the form is validated by CDER, it will be forwarded to SRP Technical Support who will enter the group information into the system.
After the group is created or a new member is added, each new member in the group including the group lead will receive an account activation email. Follow the instructions and links in the email to activate your account and create a new password.
Note: If a member is removed from the group and later join the group again, the member is considered as new and will receive an account activation email. If a member becomes a group lead, the former group lead will be removed from the group and the new group lead will receive an account activation email.
Login to SRP using your account credential and the newly created password (see following section “Your Portal Account”).