Peace, Love & Site Signature Sheet

Written by Nicole M. Pamer & John R. Nocero

Last week, Nikki and I talked about Peace and what that brings to our lives. This week, we look at defining how to obtain a peaceful and up-to-date site signature sheet. It is easy to get into a war with the site signature sheet...rather, the people that are involved in getting signatures and documenting it in real-time. It is in no way a direct smash at site personnel, but you must be able to develop these relationships with them to ensure your TMF is in a peaceful relaxed state. How do you cultivate those relationships and what does a peaceful DOAL look like for you?

Case Study

You email the clinical research coordinator (CRC) asking for the most recent site signature sheet and crickets……

You follow up in one week and request a read receipt. The CRC reads the email and you have received a read receipt but no response.

At this point, you have sent 2 emails with no response.

What's the next step?

You could:

Email the CRC one more time and see what happens.

Or…

Call the site to see why there is a delayed response.

Or….

CC' everyone and their brother in hopes you get a response back. Something is better than nothing.

Or….

Email the Principal Investigator directly.

All are possible options, but which option is the best route? I've always had the best of luck with sending 3 emails and then following up with a phone call. The secret is how many days apart do you follow up on your email and what is your relationship like with the CRC?

CC'ing everyone at the site including the PI is never helpful. It usually upsets the site and frustrates the CRC. It's rare that you will get a response from a PI when they are CC'd. Emailing the PI directly could ruin the relationship that you have with the other site study personnel. You may get an updated Site Signature Sheet quickly after that email, but you will leave a bad taste in the CRC's mouth.

There could many reasons why you are not getting a response back from the CRC. Some examples are:

-It's not current and up to date.

-CRC is new and may not know what a site signature sheet is and is used to it being called the delegation of authority log.

-CRC is out of the office

-CRC is back from out of the office and is catching up on emails.

-Site will only allow for a CRA to pick it up at their next monitoring visit.

-CRC is on multiple studies and is overworked

-Site will only send at end of the study.

-CRC does not have a good working relationship with the person who requested the site signature sheet and has flagged it as a low priority.

You know the saying, "You can get more done with honey than salt." Being kind, understanding, and compassionate with your study team doesn't cost you a thing and it only takes a minute. This little act of kindness isn't actually little. Study personnel will remember and respect you for this. In return, this simple recipe will create a peaceful and loving site signature sheet.

As always, if you have a question or want to leave a comment, please feel free- we are happy to help and love to hear from you.