Ophthalmology Protocol Planning Worksheet

Sponsor

Sponsor's Protocol Number

Protocol Title:

IRB # (if applicable):

Investigator

Phone

Pager:

Email:

Study Coordinator

Phone

Pager:

Email:

Department:

Division:

Division:

Division:

Division:

Division:

Division:

Managing Institution:

Items you're submitting for review:

Summary

Protocol

Other

Information that you need from the Ophthalmology Research Team:

Cost estimate

Please select the timeline:

ASAPwithin 2 weeks

Schedule a pre-study visit or planning meeting:

Please explain:

Other

Please describe:

Protocol Information:

How many subjects are you planning to enroll?

Anticipated start date:

Overall study duration:

Participation duration:

Number of visits and frequency:

Anticipated monthly volume:

Has the study been submitted to IRB?

YesNo

If so, please provide the IRB number:

Are there any masking requirements for the ophthalmology research team?

YesNo

If yes, please explain:

Specialties and Testing Required for Protocol (select all that apply)

Optometry (OD)

Ophthalmology (MD)

Please select sub-option for Ophthalmology:

ComprehensiveRetinaCorneaGlaucomaNeuro-ophthalmologyPediatricsPlastics

Other

Please explain:

Unknown

Diagnostic testing

Optical coherence tomography (OCT)Fundus photosHumphrey visual field (HVF)Optic nerve photosFluorescein AngiographyA-scanB-scanUltrasoundElectroretinogram (ERG)Pentacam

Other

Please explain:

Unknown

Personnel and Training:

Are there any certifications or training requirements for the ophthalmology research team?

YesNo

If yes, please list:

Are there any documents to be completed by the designated ophthalmology research team prior to initiation?

YesNo

If yes, please list:

Rooms and Equipment:

Are there any room or equipment certifications that need to be completed prior to initiation?

YesNo

If yes, please list:

Regulatory Documentation and Case Report Form:

Do you need the ophthalmology team to assist with creating and/or completing regulatory documents and/or case report forms prior to and/or throughout the study?

YesNo

If yes, please list:

Scheduling:

How far in advanced will you know a subject needs to be scheduled?

Monitoring Visits:

Will the ophthalmology department by partaking in monitoring visits in-person or remotely?

YesNo

If so, what will you need on our end?

Supplies:

Does the ophthalmology research team need to purchase any special supplies for the study?

YesNo

If so, what will you need on our end?

Will the sponsor be providing any supplies to the ophthalmology research team?

YesNo

If yes, please list the supplies that sponsor will be providing:

Miscellaneous:

Are there any additional requirements or information the ophthalmology research team should be aware of?

YesNo

If so, what will you need on our end?

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