IMACS® Site Enrollment and Regulatory RequirementsIMACS® REGISTRY HOSPITAL ENROLLMENT REQUIREMENTS
In order to be enrolled in IMACS®, the following items/forms will be requested of you:
A completed Enrollment Form
with basic contact information is the initial requirement in the enrollment process. This form plus a letter on institutional letterhead by hospital’s program director must be emailed to the IMACS® program manager at email@example.com
The Memorandum of Agreement must be completed and signed by a representative of your institution that has contractual or signing authority
. Complete and return Appendix B
IMACS® requires documentation from the hospital’s regulatory or ethics board that all local requirements for participation in the registry have been met. It is the responsibility of the participating site to determine and adhere to those requirements. For participating groups, or collectives, IMACS® will require documentation of regulatory procedures required of the collective.Note:
All documentation must be provided from an authority or representative on the Ethics Board in writing (preferably on official letterhead), rather approval is needed or not. Please see Appendix E
in the "Protocol/Appendices" section for further regulatory guidance.
It is the responsibility of the participating site to determine if Informed Consent for participation is required. Documentation is required from the regulatory or ethics board as to their policy on the Informed Consent process.
Note: All documentation must be provided from an authority or representative on the Ethics Board in writing (preferably on official letterhead), rather approval is needed or not.
At least one IMACS® staff member at the institution must complete the IMACS® training process. A live web-based entry training session will be scheduled ®with the designated staff members at each institution. The training will be conducted in English.
An IMACS® Registry user name and password will be sent for access and data entry once the above requirements are completed satisfactorily.
For a printable version of the IMACS® Registry Hospital Enrollment guidelines, please click HERE
.IMACS® REGISTRY COLLECTIVE ENROLLMENT REQUIREMENTS
The IMACS® Registry Collective enrollment requirements following steps are the same as the hospital requirements:
- IMACS® Institutional Enrollment Form
- Regulatory/Ethics Approval
- Informed Consent
The key differences are as follows:
- A Memorandum of Agreement for Collective must be completed and signed by a representative of your institution that has contractual or signing authority. Complete and return Appendix C.
- Data Transfer - After all of the regulatory requirements and paperwork have been completed satisfactorily, a data transfer will be coordinated. The collective will not be asked to enter data directly into the web based data entry system, but will be asked to provide electronic datasets that will be transferred securely to IMACS®.
For a printable version of the IMACS® Registry Collective Enrollment guidelines, please click HERE
.IMACS® REGISTRY ANNUAL RENEWAL REQUIREMENTS
To MAINTAIN CERTIFICATION, a site must
- Maintain and provide IMACS® with the annual regulatory approval (If applicable)
IMACS® will send annual reminders to the participating hospitals at least 30 days prior to expiration of regulatory approval. Lapse in providing regulatory approval to IMACS® will result in immediate suspension of data entry capability.
- Comply with data submission requirements