SVSTDTC after RFPENDTC issue (SD1202)

SVSTDTC after RFPENDTC issue

Hi Pierre,

You talk about "end of study visit", but at the same time you state "--STDTC" which is "start of...".

Hi,…

Hi,

SVSTDTC and SVENDTC have the same date value.

SVSTDTC after RFPENDTC issue (SD1202)

Hi Pierre,

I still have problems understanding this. In your case, can there be a "visit" without a "contact"? What I mean is that you have a "last contact", can there still be a visit after that? Or is that a visit without the subject taking part in it?
I checked in the SDTM-IG 3.2. It says for RFPENDTC "as defined in the protocol". I can however find no statement that there is rule that it is not allowed to have a visit after RFPENDTC. Neither can I find this rule in the CDISC "SDTMIG v.3.2 conformance rules". As it is a rule starting with "SD" it cannot be an FDA rule either as the latter all start with "FDAC".

Hi,…

Hi,

Yes, you guessed right, there could be a "visit" without a contact. The investigator has to fill out the End of Study form at the end of the trial and this is considered as a visit. In this form, the investigator has to enter the status of the patient (completed, lost to follow up...) and the date of last contact. Obviously, if the patient shows up for the End of Study visit, the last contact date will be the same as the End of Study visit, but if the patient is lost to follow up and never shows up for the End of Study visit, the investigator will enter the date of last contact as the last time the patient was seen.

I'll document in the SDRG if needed but I see the rule is not clear

This is not a Visit

Hi Pierre, 

I believe that a definition of "Visit" is based on an event when a study subject visiting an investigator site. In your example, a completion of some forms by an investigator without involving a study subject cannot be considered as a Visit.

Regards, 

Sergiy

The Definition of Visit is Subjective

Per the IG, Section 7.1.2 Definitions of Trial Design Concepts:

Visit: A clinical encounter. The notion of a Visit derives from trials with outpatients, where subjects interact with the investigator during Visits to the investigator's clinical site. However, the term is used in other trials, where a trial Visit may not correspond to a physical Visit. For example, in a trial with inpatients, time may be subdivided into Visits, even though subjects are in hospital throughout the trial. For example, data for a screening Visit may be collected over the course of more than one physical visit. One of the main purposes of Visits is the performance of assessments, but not all assessments need take place at clinic Visits; some assessments may be performed by means of telephone contacts, electronic devices or call-in systems. The protocol should specify what contacts are considered Visits and how they are defined.

If the protocol specifies that the end-of-study assessment is a visit, then so be it.  This makes sense, otherwise, concepts such as "Lost to Follow-up" would be outside the definition, wreaking havoc with when/how to categorize various end-of-study activities that might not directly engage with the subject.  

Looking at the definition for RFPENDTC (bolding my own):

Date/time when subject ended participation or follow-up in a trial, as defined in the protocol, in ISO 8601 character format. Should correspond to the last known date of contact. Examples include completion date, withdrawal date, last follow-up, date recorded for lost to follow up, or death date.

This seems to include the concept described here ("In this form, the investigator has to enter the status of the patient (completed, lost to follow up...) and the date of last contact.", and I would expect DM.RFPENDTC to account for this date.

As a last point: I agree the check is more about data quality than conformance, in that, while the end of a subject's participation is most likely the same as the latest date associated with the subject within the study data, it is not necessarily so.  An example:

• The PP (Pharmacokinetic Parameters) domain variable PPDTC is the "Date/Time of Parameter Calculations", defined as the "Nominal date/time of parameter calculations".  
• This could easily be after RPFENDTC in, say, a short PK study, and could even be associated with a visit in the dataset, although well after the visit date as captured in the associated PC data.

Regards,

Carlo