policies & procedures

Certification for Photographers at Sites

Photographers are certified for acquisition of the imaging modality they will be using either by two senior graders at the OIRRC or by a recognized reading center. Reading centers recognized by the OIRRC are:

  • University of Wisconsin Reading Center (UWFPRC)
  • Doheny Image Reading Center (DIRC)
  • The Digital Angiography Reading Center (DARC)

 

Dedicated Project Manager

A member of the senior staff at OIRRC is assigned to lead the project at the beginning of the study. All communications between OIRRC and sponsor and CRO are handled directly by the project manager.

 
OIRRC Image Acquisition and Submission Protocol

An image acquisition and submission protocol will be prepared for the study and the specific sites that are involved in 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 data secure databases and how to get a username and password for users at site.
 
Turn around time (TAT)

Screening Visit Images: 24 hours

Equipment Certification: 48 hours

Photographer Certification: 48 hours

 

Image Grading

Two independent certified graders review and grade all images. If there is any disagreement between the two graders a third senior grader reviews the images. For image grading required for patient selection and randomization purposes two senior graders are involved.

 
Grading Forms

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.

 
Quality Control

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 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.

 
Investigator Meeting

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.

 
Study Updates

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.

 
Customer Support

Telephone Assistance:

  • 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:

  • 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.