This DRAFT guidance supercedes FDAs issued guidance on electronic source data in clinical investigations (eSource guidance).  In the eSource guidance, FDA addresses attributes of source data used to fill predefined fields in an eCRF that would satisfy FDA's inspection, recordkeeping, and record retention requirements.  The guidance acknowledges that data entering the sponsor's eCRF may be derived from a variety of sources, including EHRs.  This guidance clarifies FDA's expectations when EHRs are used as a source of data in clinical investigations.  

    

This draft guidance provides the following recommendations:

• Deciding whether and how to use EHRs as a source of data in clinical investigations
• Using EHRs that are interoperable with electronic systems supporting clinical investigations
• Ensuring the quality and the integrity of EHR data that are collected and used as electronic source data in clinical investigations

Click here to view the guidance in its entirety. 

 

1 lb Roma tomatoes, chopped
1 English cucumber, sliced 1/2 lengthwise then chopped
1/2 medium red onion, sliced
2 avocados, diced
2 Tbsp extra virgin olive oil
Juice of 1 medium lemon or lime 

1/4 cup (1/2 bunch) cilantro, chopped
1 tsp sea salt  

1/8 tsp black pepper

Preparation:

1. Place tomatoes, cucumber, red onion, avocado, and cilantro into a large salad bowl.

2. Drizzle with olive oil and lemon or lime juice. Toss gently to combine. Just before serving toss with sea salt and black pepper.
 

Levi Machado, CCRP

IRB Coordinator/Co-chair

 

Levi has been with IntegReview for 8 years and the past 4 years have been focused on IRB Coordinator/Co-chair responsibilities, which include the planning, conduction, and follow-up of weekly board meetings. As a voting board member, he is responsible for the review of new study submissions and study documents that qualify for expedited review while complying with government regulated guidelines in regards to the protection of human subjects.  Levi  enjoys spending time with his family and being outdoors.  His hobbies include hiking, swimming, playing softball and spending time at the Austin Greenbelt. 

Jami's primary responsibility as Assistant Coordinator is to provide assistance to the IRB Coordinators/Co-chairs with all activities associated with the planning, conduction, and follow-up of IRB meetings.  She has an Associate's degree in Surgical Technology, and maintains this certification with future plans to donate time to surgical mission trips. Jami and her husband, Rick, have 3 children, Chloe (19), Canaan (16), and Gavin (15). In her free time, Jami enjoys baking, reading, traveling, and spending time with her family and numerous pets. 

 

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We see a lot of...interesting looks on flights these days. Sweatpants. Leggings worn as pants. Scarves the size of blankets. Socks with sandals. Gone are the days of suits and hats (though many travelers make the case for bringing a little civility back to the skies), and in their place: short shorts.

Read entire article here:  Why There Should be a Dress Code for Flying