policies & procedures
Certification for Photographers and Devices at Sites
Photographers and Devices are certified for acquisition of the imaging modality they will be using by certification officers at the OIRRC.
Dedicated Project Managers
At least one member of the project management team at OIRRC will be assigned to lead the project throughout the course of the study. All communications between OIRRC and sponsor and/or CRO are handled directly by the project manager.
OIRRC Image Acquisition and Submission Protocols
Image acquisition and submission protocols will be tailored to the specific requirements of the study. This protocol contains the following information:
- Image acquisition manuals for various imaging modalities
- Guidelines for secure data transfer
- Log in instructions for sites to upload to OIRRC's secure databases and how to get a username and password for users at site
Turn around time (TAT)
Eligibility: Tailored to study design (2 hour minimum)
Equipment Certification: 2-3 business days (standard)
Photographer Certification: 2-3 business days (standard)
Quality Control of Study Images: 2-3 business days (standard)
Data Transfers: 6 weeks from data cut (standard)
*All turn-around-times can be negotiated to fit study needs
Certified graders review and grade all images. 90% of OIRRC graders are physicians in the ophthalmology field. Multiple grading configurations, depending on the needs of a particular study, are possible.
Grading forms for each imaging modality are developed for the study by the OIRRC and approved by the sponsor. Approved grading forms are converted into electronic versions that will be filled by graders to eliminate the chances of human error during data transfer from paper to electronic databases.
All images received are checked for consistency with the acquisition protocol provided to the sites before being presented for evaluation to the graders. QC personnel ensures that the images received at every visit belong to the same patient and are obtained by the same certified photographer.
Data Transfer Agreement
Guidelines for transfer of grading data are set in place before the start of each project in collaboration with the sponsor and/or the CRO. OIRRC will ensure the sponsor receives data in a format that is requested.
Data Storage Center
Data is stored on a secure server that meets the appropriate safety and regulatory recommendations and is backed up on a separate backup server on a nightly basis. The backup server is in a physically separate location.
OIRRC works hand in hand with study sponsor to prepare for such important meetings. A 2 to 3-member team from the OIRRC will assist in organizing a breakout session to introduce the photographers and coordinators (PIs not excluded) to the study specific image acquisition and submission protocol. The OIRRC team can travel to attend investigator’s meetings upon request from the sponsor.
A monthly tracker of images received from the sites is shared with the sponsor. Sponsor is copied on all communications between the OIRRC and participating sites.
- Telephone assistance is provided by OIRRC members i.e. clinical research managers and clinical research coordinators, 24/7. In the event of absence of one member, the call is forwarded to the next member ensuring prompt assistance. In the event of absence of OIRRC staff, for staff travel or research meetings, a voice message can be left for the concerned OIRRC member who promptly responds.
- Any attempt made at telephone communication after working hours or on holidays is addressed by the on-call OIRRC member.
- Email assistance is provided during the working hours i.e. 9 a.m. to 5 p.m. Any email communication made after working hours is addressed on the next working day.
- Any issue that requires opinion of another colleague or the Director of OIRRC, is discussed amongst the team and addressed accordingly. The vendor/caller is informed of the possible delay in the customer support in such cases. The customer is informed of the feedback and rationale for the decision behind the feedback.
- All the communication made via the email portal, if related to a subject enrolled in a clinical trial is strictly de-identified. To ensure the confidentiality and security of the patient data, any data transfers are only done via secure web portals assigned to/ given access to OIRRC by the vendors, or by OIRRC to the vendors.