Types of Visit (Time points)
- Persistent Visit
- Defined Window Period
- Custom Start/End Date
Participants will always be able to view and attempt (at their own time) all the questionnaires hosted under a Persistent Visit. These questionnaires will appear to the participant after he/she is accepted into the ClinDATC system until the day he/she exits the clinical study. Coordinators are not involve in initiating this type of visit but are required to configure it beforehand.
Case Study Example
For most of the clinical studies conducted, relevant bio info about the participants are collected.
Midway through the study, a participant might get married, change Address or Contact no. hence his/her personal information (Marital status, Residential address and Contact) needs to be updated.
A second example will be drug allergies. Participants may forget to list down all the allergies during enrollment but he/she will be able to update conveniently as and when needed.
Defined Window Period
ClinDATC is distinctive to have incorporated this ‘automated publishing of questionnaires to participants’ feature into it’s visit system which other data collection software will probably not have. This type of visit will enabled automatically on a date derived from a fixed number of days from First Date (e.g. registration date). When this visit is enabled, the participants will be able to view and attempt questionnaires associated to it. Coordinators are not involve in initiating his type of visit but are required to configure it beforehand.
Case Study Example
Let’s explain this by using a case study on Diet Management. A participant takes in certain food for 2 months (1st and 2nd month) and the study will conduct a series of questionnaires on the 3rd month. Thereafter, the participant will change his/her diet for the next 3 months (4th, 5th and 6th month) and the study will conduct a series of questionnaires on the 7th month.
Graphically, it will look like this (1m denotes 1st month)
Phase 1: 3 months (inclusive 1 month for attempting questionnaires)
Phase 2: 4 months (inclusive 1 month for attempting questionnaires)
Total study period per participant = 7 months
Participant A joins the study on 1 January 2015 (2015-01-01). The study coordinator enrolls Participant A whereby the Defined Window Period is planned and configured into the system beforehand.
‘FD’ denotes First Date which can also be Registration date or Official study Start date for the participant.
2015-01-01 (FD) + 60 days (configured) = 2015-03-01 where 60 days is the period of time he/she takes in food
2015-01-01 (FD) + 90 days (configured) = 2015-04-01 where difference of 30 days (90-60) is the 1st visit where a series of questionnaires will appear whenever he/she logins.
Hence, from 2015-03-01 to 2015-04-01, he/she have got a 30 days grace to finish the series of questionnaires.
On 2015-04-01 (1st April the 4th month), he/she will change diet for 2 months before a new set of questionnaires is given on the 7th month.
2015-01-01 (FD) + 180 days (configured) = 2015-07-01 where last 90 days is the period for diet 2.
2015-01-01 (FD) + 210 days (configured) = 2015-08-01 where difference of 30 days (210-180) is the 2nd visit where next series of questionnaires will appear whenever he/she logins.
Hence, from 2015-07-01 to 2015-08-01, he/she have got a 30 days grace to finish the 2nd series of questionnaires.
The REAL beauty of this feature is that the Defined Window Period is associated with each participant.
Let’s face it, it is near impossible to recruit 500 participants on the SAME day!! – participants will have different First Date (FD). And ClinDATC is able to stagger the study phase for each participants by the use of First Date (FD) entered by coordinator.
Custom Start/End Date
This is an event-driven visit. It means that the Start/End date of the window period is Enabled because a definite event (usually planned before a study starts) had occurred. The coordinators are required to login to his/her ClinDATC account, locate this participant and Enable the window period manually. On the participant’s end, he/she will be able to view this new visit and attempts the series of questionnaires associated to it.
Case Study Example
A study recruits 200 females whom plan to give birth within the next 1-2 years. There is a ‘Pre-conception’ visit with some lifestyle and diet questionnaires which all the mothers-to-be need to attempt.
One month later, Participant A called up the coordinator and inform she is pregnant! Coordinator will login and enable the hidden ‘Pregnancy’ visit for this Participant A only. This second visit hosts questionnaires related to the 9 months pregnancy duration, e.g. which hospital, gynaecological visits expenditure and change of lifestyle during pregnancy etc.
Nine months later, Participant A called up the coordinator again and inform she had delivered. Coordinator will login and Enable the hidden ‘Delivery’ visit for this Participant A only. This third visit hosts questionnaires related to the baby after delivery, e.g. gender, weight and milk formula etc.