You've submitted your Site Suitability Assessment Survey (SASS), completed the team feasibility interview, and have been accepted into the MISTIE-III consortium. Congratulations! Now what are the next steps? Your "Startup Sherpa" (a/k/a your site manager) will guide you on this next step "up the mountain" but here's a brief summary of the steps and some important links.
You must book your hotel room no later than 18-October, so be sure to read all the details below!
We will send you a bunch of documents to complete, and a list of things to compile such as the FDA-1572, CVs, Delegation Log, lab normals and certifications, etc.
Send us any site-specific revsions to the draft consent for review.
Submit IMMEDIATELY to your IRB and contracts department.
Complete the VISION EDC Basics Course and send us the course certificate (generate this after successfully passing the online quiz) along with your signed Electronic Signature User Agreement (see download below). Anyone requiring access to the EDC (coordinator, investigator, reg. doc. manager, etc.) must do this to get access to the EDC.
EDC Electronic Signature & Patient Health Information Agreement
Complete the Electronic Trial Master File (eTMF) course and send us the course certificate. This is a required course for the coordinator and anyone else that will be uploading documents (source docs, dicom imaging files, reg. docs, etc.).
Book your hotel room for the Investigator's Meeting in Baltimore. Details on the flight arrangements will follow soon.
NIH-NINDS MISTIE III Investigator Coordinator Meeting
Start date: Friday, 08-Nov-13 -- plan to arrive by 4PM for an evening reception
End date: Sunday, 10-Nov-13 -- plan to leave 2PM. A box lunch will be provided.
Last day to book by: 10/18/13
BWI Airport Marriott for 109.00 USD per night
Use this link to ensure you get the group rate: NIH-NINDS MISTIE III Investigator Coordinator Meeting