© European Medicines Agency, 2021
Process Puzzle
How to respond to Requests for
Information received during the
evaluation of a CTA
CTIS Training Programme – Module 11
Version 1.1 – February 2021
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material to enhance public access to information on the Clinical
Trial Information System (CTIS). This material describes a
preliminary version of CTIS and may therefore not entirely
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 Case scenarios process puzzle exercises

In this exercise we invite you to reflect on the steps you need to follow to

access and respond to RFIs received during the evaluation of a CTA by
means of a visual representation: a process puzzle.

Flow of the activity

1 2 3 4 5

Master trainer explains Participants are Participants review Participants organise Group discussion
the exercise and divided in groups carefully the case their process puzzle of the outcome of
examples (if possible) scenario assigned case scenario the exercise
 Example of a process puzzle

The example below visualises one way to view and access Requests for Information. You will organize puzzle pieces
following the same logic by dragging and dropping the figures to create a correct sequence of steps or actions.

RFI tab

RFI identifier
number
Login to CTIS Click on the
sponsor RFI identifier
workspace number
Open the RFI Click on the
tab to find a list lock button to
of the RFIs work on an RFI
received response

1 2 3 4
 Order the pieces of the process puzzle
RFI received during
Case scenario 1 validation phase

A sponsor has a multinational CTA under evaluation and has received one RFI from the RMS. Let’s consider that
responding to the RFI does not require any change to the submitted CTA. Drag and drop the pieces to
show a possible sequence of steps that the sponsor should follow to respond to that RFI.
Review
the RFI Review the
Respond supporting RFI
Review the Save the to the documents Add description
considerations responses considerations Submit the provided by documents
to the in writing RFI response MSC related to the
considerations response if
needed

Locate the
related RFIs

Drop here Drop here Drop here Drop here

Solution: Nº 1 Nº 3 Nº 5 Nº 7

What can Drop here

Drop here Drop here
happen after? Nº 2 Nº 4 Nº 6
There may be
more than one
correct flow
 Order the pieces of the process puzzle
RFIs received during
Case scenario 2 validation phase

A sponsor has a multinational CTA under evaluation and has received two RFIs: one related to Part I and
another related to Part II, both require changes to the CTA. Drag and drop the pieces to show a possible
sequence of steps that the sponsor should follow to respond to both RFIs.
Change or
Respond update
and save the documents in
responses to the CTA
Review the considerations Submit the
considerations in writing
Submit the Change or RFI to Part II
of RFI part I Respond Review the
RFI to Part I update response
and save the considerations
response documents in responses to of RFI part II
the CTA considerations
Locate the in writing
related RFIs

Drop here Drop here Drop here Drop here

Solution: Nº 1 Nº 3 Nº 5 Nº 7

What can Drop here Drop here Drop here Drop here
happen after? Nº 2 Nº 4 Nº 6 Nº 8
There may be
more than one
correct flow
 Order the pieces of the process puzzle
RFIs received during
Case scenario 3 assessment phase

A sponsor has a mononational CTA under evaluation and has received two RFIs: one related to Part I and
another related to Part II, both require changes to the CTA. Drag and drop the pieces to show a possible
sequence of steps that the sponsor should follow to respond to both RFIs.
Change or
update
Add documents in
Respond
documents Change or the CTA
Review the Submit the to the
related to the update Review the
considerations RFI response considerations
response if Add Save the documents in considerations
in writing Respond
needed documents responses the CTA Save the
Submit the to the responses
related to the to the
RFI response considerations to the
response if consideration
in writing consideration
needed

Locate the
related RFI Solution Drop here Drop here Drop here Drop here Drop here Drop here
RFI Part I: Nº 1 Nº 2 Nº 3 Nº 4 Nº 5 Nº 6
and click on
the lock
button
What can
happen after?
Solution Drop here Drop here Drop here Drop here Drop here Drop here
There may be RFI Part II: Nº 1 Nº 2 Nº 3 Nº 4 Nº 5 Nº 6
more than one
correct flow
 Bonus activity!

You can add more complexity to the process puzzle through the following:
• Break down into two different figures steps that are presented as one in case scenario 2 (i.e. Respond and save the
responses to considerations in writing)
• Narrow down some steps to include more figures in some of the cases (e.g. “click on the lock button”; instead of
“change or update documents in the CTA”, you can have different figures with “change structured data”, “add new
documents”, etc.).

To include new pieces you will need to create new figures in slide 3:
• Select a figure, right click on it and select ‘copy’ and then ‘paste’
• Select the figure, right click on it and select ‘edit text’
• Write the name of the step/action
• Drag the figure and place it where necessary
• Be mindful of the color figures. Tip: use the same color for similar steps/actions. 
 Order the pieces of the process puzzle Proposed solution
Bear in mind that this slide is an example of
what the outcome of the activity can look like.
RFI received during
Case scenario 1 validation phase

A sponsor has a multinational CTA under evaluation and has received one RFI from the RMS. Let’s consider that
responding to the RFI does not require any change to the submitted CTA. Drag and drop the pieces to
show a possible sequence of steps that the sponsor should follow to respond to that RFI.

Add
Locate the Review
Review the documents
Submit the RFI
related RFI the RFI related to the
considerations response
description response if
Review needed
Save the
the RFI Respond
responses
supporting to the
to the
documents considerations in
considerations
What can provided writing
happen after? by MSC

There may be
more than one
correct flow
 Order the pieces of the process puzzle Proposed solution
Bear in mind that this slide is an example of
what the outcome of the activity can look like.
RFIs received during
Case scenario 2 validation phase

A sponsor has a multinational CTA under evaluation and has received two RFIs: one related to Part I and
another related to Part II, both require changes to the CTA. Drag and drop the pieces to show a possible
sequence of steps that the sponsor should follow to respond to both RFIs.

Locate the Respond Respond

related RFIs Review the and save the Review the and save the
considerations of responses to considerations responses to
RFI part I considerations of RFI part II considerations
in writing in writing
Change or Change or
Submit the  Submit the
update update
 response to the response to the
documents in documents in
What can Part I RFI Part II RFI 
the CTA the CTA
happen after?
There may be
more than one
correct flow
 Order the pieces of the process puzzle Proposed solution
Bear in mind that this slide is an example of
what the outcome of the activity can look like.
RFIs received during
Case scenario 3 assessment phase

A sponsor has a mononational CTA under evaluation and has received two RFIs: one related to Part I and
another related to Part II, both require changes to the CTA. Drag and drop the pieces to show a possible
sequence of steps that the sponsor should follow to respond to both RFIs.

Add
Save the
documents
Review the responses
related to the
considerations to the
Solution response if
Change or Respond consideration
RFI Part I: needed
update to the Submit the RFI
documents in considerations response
Locate the the CTA in writing
related RFI
and click on
the lock
button Add
Save the
documents
Review the responses
Solution related to the
considerations to the
What can response if
RFI Part II: Change or Respond consideration
happen after? needed
update to the Submit the RFI
There may be documents in considerations response
more than one the CTA in writing
correct flow