Pfizer Docs: Addendum to CRFs
Addendum to Part 6: A better visualization of the participant records.
This one’s a bit on the boring side (like any of these Pfizer document posts have been exciting) and is only really useful if you plan on combing through the participant records from the clinical study. So my feelings won’t be hurt if nearly everyone skips the whole thing.
After finishing the explanation of participant records and Case Report Forms (Pfizer Docs Part 6: Case Report Forms), I had a nifty little spreadsheet cataloging all the pages of one participant record. Reorganizing this spreadsheet, I realized it’s a bit easier to visualize in this format.
Once again, we’re looking at the record for participant 10851018, which is contained in this file:
125742_S1_M5_CRF_c4591001-1085-10851018.pdf
Organizing by visits, there are scheduled visits and unscheduled visits. There are twenty visits in this record and some have occurred, while some are still pending. Some of the Forms have comments and history files while others don’t.
Here’s the spreadsheet (broken into three images):
Pages 1-109
Recall this system organizes data by “visits” some of which don’t really involve the subject in person, but are just data entry activities. The first column in my spreadsheet shows all the visits, and the second column shows the visit date (if it has occurred, obviously). Pages 1-109 in this record are the Forms that were used to record data from those visits.
Pages 110-253
These are Comments Forms. Users can add comments, and when they do a Comments Form is generated for the Form being commented on. They’re not required to make comments so not all Forms will have a Comments Form.
Pages 254-255
These two pages are the Signature History for this record, and page 254 is linked to the CASEBOOK SIGNATURE FORM on page 108. The Signature History Form comes after the Comments Forms and is linked as they would be. For the lawyers out there, this Form contains the affidavit attesting the record is accurate.
Pages 256-423
These are the eCRF Audit Trail History Forms. The easiest way to determine if a visit has occurred is to see if there’s an eCRF Audit Trail History for that visit’s Forms. The first time data is entered in a Form an eCRF Audit Trail History is automatically generated.
This same Form gets a new line every time someone adds or changes data on the corresponding Form. If no data has been entered into a Form yet, there is no eCRF Audit Trail History.
In the spreadsheet, the Forms with no eCRF Audit Trail History have been grayed out so we can clearly see which visits haven’t occurred. For example visits 5 and 6 in this participant record, which are the 12 month and 24 month follow-up visits, have not yet occurred.
A few more notes on reading the Forms
This is the first page in the record for subject 10851018. It’s also the first Form, COHORT SELECTION.
Here’s the most useful thing you should know if you’re reviewing these records
In the image above there is a line of blue text that says “eCRF Audit Trail History.” This pdf file contains live hyperlinks, so if you click on that (and are using a pdf viewer) you will jump directly to the page that contains the eCRF Audit Trail History. That page has a link “Back to Form” that will take you back to where you started.
But pages 32-35, for example, don’t have this hyperlink because those Forms have not yet been filled out - so there’s no eCRF Audit Trail History to jump to.
You don’t need to search the file to find the Comments or eCRF Audit Trail History pages, you can jump to them directly via the hyperlinks. Keep in mind these pages are all at the end of the file - if you’re just scrolling through the pages, once you get to the first Comments page you’ve seen all the relevant data entry Forms.
Note on dates
There are a lot of dates on this Form, but none of them is the date the Form was filled out. Pfizer uses dates as version numbers - for example the Form on page 1 is COHORT SELECTION Version 30-Jul-2020 21:29.
The “Generated Time (GMT)” is the time this record was output from the system for submission to the FDA (29-Mar-2021 10:22). This is given in GMT (Greenwich Mean Time1).
The Form we’re looking at contains two questions for the user to answer:
Select appropriate response - Protocol version
Select appropriate response - What cohort does the subject belong to?
And we can see the responses from the user:
30 JUN 2020
STAGE 3 COHORTS
That date is the protocol version, which is at version 30 Jun 2020.
To find out when this Form was filled out, we need to read the eCRF Audit Trail History, which was created automatically when the data was entered.
This Form shows us the two lines on the COHORT SELECTION Form that the user was editing.
On Aug-01-2020, user Banika Ervin entered “30 JUN 2020” for the item on the fist line of the Form. We can see the question this user was answering listed above the entry: “1. Select appropriate response - Protocol version” and the reason given is “initial entry.”
All of the eCRF Audit Trail History Forms will have an initial entry for each item, and that will be the only entry if it was never changed. If edits were made to any of the items it shows the changes and the reasons given.
One last note about filling out standard forms
Many companies require specific placeholders on forms before any data is entered. In these Forms it appears Pfizer’s uses “//” as their standard placeholder.
We’re done with CRFs for now
If you plan on looking through these participant records, hopefully you know how to find what you’re looking for even if the pdf files contain dozens of participant records and thousands of pages.
Remember we only have 52 of these records so far, and based on the average length the total participant record page count could be 11 million pages for the whole study.
It’s best to know how to look for things before going fishing in a lake that big.
https://time.is/GMT