Many of
you are probably also familiar maybe with the regulatory documents
and many sponsors require these to be captures
within an actual study binder or some sort of confined document.
They may include the study itself as well as any amendments,
the drug brochure, the forms 1572, which is a really important form
for investigators to complete, all the CVs of the personnel
that are listed on the 1572, any IRB information, or approvals,
correspondence, all the IND safety reports, and the site
safety reports that have been submitted to the IRB.
Also should include the IRB-approved consent documents, any advertisements
that have been used, the IRB membership list, investigational drug inventories,
telephone logs that may have been used to document the tracking
of what's going on with the study, any copies of lab certifications, CLEAR
reports, logs documenting CRA visits, as well as signature logs,
and then the close out letter would all -- those documents would be included
within the regulatory documents, or the binder.
NIH also does have documents that they like to have.
If any of you are the NIH employees,
which many of you are, that you be familiar with these.
You know, the human subjects protection training, conflict of interest documents,
disclosing finance interests, as well as the Data Safety Monitoring
Board plan is included with any of our grant applications
that we have, as well as all our research
programs are required to have that.
What is the data-sharing policy, as well as how to adequately include
a plan for and include minorities, women, and children within your research?
Record retention.
How long to determine to keep records is a question I often receive.
When some of these studies go on for years and years, these research sites
can have a lot of data, a lot of records that they have on in storage.
And it can become quite expensive.
Many sites are now transferring that information into electronic
capture system by scanning and trying to reduce the burden.
But it's difficult to find concrete information
on what timeline records should be retained.
There are some minimums, though, that --
and usually the sponsor will define that.
But for minimums, two years following the date
the marketing application is approved for any investigational
new drug is a standard.
And if the application is disapproved, then the data should be maintained
for two years after the shipment and delivery of the drug for
the investigational use is discontinued and the FDA is notified.
All IRB records should probably
be maintained for at least three years after the study is completed.
And some of these studies can go on for many years,
so that's a long time to maintain.
As far as follow-up and analysis, you know, no further
participant enrollment is a timepoint that follow-up needs to be determined.
How long does that need to go out?
How much data needs to be collected during this phase?
Hopefully, just minimum amounts because the, you know, funding
is going to be far less at this time point.
Think about data queries in preparation
for the final analysis, once this is completed, the data is frozen,
and you can't enter, sites can't enter more information into the data system.
So they want to get that information in before that time point.
And then the study close out is an intense review that, again, is done
by the sponsor in which they review the regulatory documents,
they look at any outstanding CRFs and queries,
they look at the drug inventory, they verify that all SAEs
have been reported to the IRB and the sponsor.
Any remaining drug is returned and then arrangements for the drug's
record storage are discussed and determined.
So basically, there are some key pieces to keep in mind
as far as guiding principles of data management.
Again, designing CRFs in accordance with the protocol and doing them
in a method that makes sense and are user friendly are key.
Standardized data entry procedures and processes.
Stay organized.
I, you know, being a compulsive, I think is a key attribute for people
who are involved in research because they tend to be
the ones that want to pay strong attention to detail.
Don't get behind because it's so difficult to get caught back up.
Easier said than done.
And then thorough and complete documentation is key.
And again, I provide you some resource websites
that you an use, as well as some additional references
for some of the information that I provided within the slides.
You can go to these and review it in more detail, if you like.
And so with that, I'd be happy
to take any questions anyone might have.
Okay, I'm not seeing any questions, which is just fine.
We're right at the end of the time period.
So I thank you for your attention, and I think if you come up with questions
later, there's the opportunity to send them to me.
I'll see what I can do to happily answer those as well I can, or find the
answers for you. Thank you.