brad@brad
184 Posts
Quote from brad on June 27, 2022, 9:35 pm
We communicate with patients in just every possible way nowadays - text, email, phone calls, maybe even via social media. Do you ever print these communications and put them in the subject binder? We've just been asked to print all text exchanges we've ever had with subjects in a particular trial. Of course we are 2+ years in and consented 75+ patients so it's a lot to track down. I suppose it makes sense to have record of these conversations but I've never done this proactively. Anyone do this as part of their regular logging of communication with their patients?
We communicate with patients in just every possible way nowadays - text, email, phone calls, maybe even via social media. Do you ever print these communications and put them in the subject binder? We've just been asked to print all text exchanges we've ever had with subjects in a particular trial. Of course we are 2+ years in and consented 75+ patients so it's a lot to track down. I suppose it makes sense to have record of these conversations but I've never done this proactively. Anyone do this as part of their regular logging of communication with their patients?
Hightower Clinical / Note to File Podcast / Existential Dilettante / "Specialization is for insects"
brad@brad
184 PostsTopic Author
Quote from brad on June 28, 2022, 2:34 pm
Quote from Guest on June 28, 2022, 5:15 am
We don’t print these out but do have a record of these communications on Zoom.
On Zoom?
We have the record, obviously, but usually won't print it out. We do document relevant communications (AEs/SAEs, etc) so I'm not sure why that isn't enough. I'm not opposed to printing them but hate doing it so long after the fact. Just trying to get a pulse as to whether other sites do it proactively or if it's just us who generally doesn't.
Quote from Guest on June 28, 2022, 5:15 am
We don’t print these out but do have a record of these communications on Zoom.
On Zoom?
We have the record, obviously, but usually won't print it out. We do document relevant communications (AEs/SAEs, etc) so I'm not sure why that isn't enough. I'm not opposed to printing them but hate doing it so long after the fact. Just trying to get a pulse as to whether other sites do it proactively or if it's just us who generally doesn't.
Hightower Clinical / Note to File Podcast / Existential Dilettante / "Specialization is for insects"
brad@brad
184 PostsTopic Author
Quote from brad on June 29, 2022, 12:16 am
Quote from
Jeanette on June 28, 2022, 8:50 pm
If it is not documented in the protocol that text messages have to be kept as part of the source, we will not keep them as part of the source. It is a form of communication, no different than a phone call. We do not document every single phone call that we have with the subject; we only document the interactions that are relevant to the study. If a subject calls to confirm their appointment time, this interaction will not be documented. It is not necessary, and that would be silly. Same with text messages. If a text message communication has information that is important to the conduct of the study, we will document the interaction, but we will not print the transcript the of that text communication - nor would we have a transcript of our telephone conversation.
I would push back on the CRO/Sponsor. If they want the transcripts printed for source, ask to be shown where this is instructed in the protocol. It would not be a deviation if it is not written to have these transcripts as part of source.
I tend to agree with this though I find it interesting there's no clear consensus. Appreciate your feedback as always.
Quote from
Jeanette on June 28, 2022, 8:50 pm
If it is not documented in the protocol that text messages have to be kept as part of the source, we will not keep them as part of the source. It is a form of communication, no different than a phone call. We do not document every single phone call that we have with the subject; we only document the interactions that are relevant to the study. If a subject calls to confirm their appointment time, this interaction will not be documented. It is not necessary, and that would be silly. Same with text messages. If a text message communication has information that is important to the conduct of the study, we will document the interaction, but we will not print the transcript the of that text communication - nor would we have a transcript of our telephone conversation.
I would push back on the CRO/Sponsor. If they want the transcripts printed for source, ask to be shown where this is instructed in the protocol. It would not be a deviation if it is not written to have these transcripts as part of source.
I tend to agree with this though I find it interesting there's no clear consensus. Appreciate your feedback as always.
Hightower Clinical / Note to File Podcast / Existential Dilettante / "Specialization is for insects"
