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Many of

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you are probably also familiar
maybe with the regulatory documents

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and many sponsors
require these to be captures

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within an actual study binder
or some sort of confined document.

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They may include the study itself
as well as any amendments,

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the drug brochure, the forms 1572,
which is a really important form

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for investigators
to complete, all the CVs of the personnel

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that are listed on the 1572,
any IRB information, or approvals,

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correspondence,
all the IND safety reports, and the site

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safety reports
that have been submitted to the IRB.

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Also should include the IRB-approved
consent documents, any advertisements

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that have been used, the IRB membership
list, investigational drug inventories,

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telephone logs that may have been used
to document the tracking

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of what's going on with the study,
any copies of lab certifications, CLEAR

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reports, logs documenting CRA visits,
as well as signature logs,

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and then the close out letter would all --
those documents would be included

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within the regulatory documents,
or the binder.

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NIH also does have documents
that they like to have.

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If any of you are the NIH employees,

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which many of you are,
that you be familiar with these.

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You know, the human subjects protection
training, conflict of interest documents,

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disclosing finance interests,
as well as the Data Safety Monitoring

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Board plan is included
with any of our grant applications

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that we have, as well as all our research

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programs are required to have that.

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What is the data-sharing policy,
as well as how to adequately include

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a plan for and include minorities,
women, and children within your research?

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Record retention.

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How long to determine to keep
records is a question I often receive.

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When some of these studies go on for years
and years, these research sites

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can have a lot of data, a lot of records
that they have on in storage.

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And it can become quite expensive.

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Many sites are now transferring
that information into electronic

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capture system by scanning
and trying to reduce the burden.

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But it's difficult
to find concrete information

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on what timeline records
should be retained.

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There are some minimums, though, that --

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and usually the sponsor will define that.

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But for minimums, two years
following the date

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the marketing application is approved
for any investigational

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new drug is a standard.

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And if the application is disapproved,
then the data should be maintained

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for two years after the shipment
and delivery of the drug for

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the investigational use is discontinued
and the FDA is notified.

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All IRB records should probably

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be maintained for at least three years
after the study is completed.

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And some of these studies
can go on for many years,

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so that's a long time to maintain.

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As far as follow-up and analysis,
you know, no further

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participant enrollment is a timepoint
that follow-up needs to be determined.

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How long does that need to go out?

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How much data needs to be collected
during this phase?

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Hopefully, just minimum amounts
because the, you know, funding

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is going to be
far less at this time point.

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Think about data queries in preparation

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for the final analysis, once
this is completed, the data is frozen,

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and you can't enter, sites can't enter
more information into the data system.

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So they want to get that information
in before that time point.

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And then the study close out
is an intense review that, again, is done

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by the sponsor in which they review
the regulatory documents,

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they look at any outstanding CRFs
and queries,

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they look at the drug inventory,
they verify that all SAEs

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have been reported to the IRB
and the sponsor.

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Any remaining drug is returned
and then arrangements for the drug's

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record storage are discussed
and determined.

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So basically,
there are some key pieces to keep in mind

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as far as guiding principles
of data management.

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Again, designing CRFs in accordance
with the protocol and doing them

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in a method that makes sense and are user
friendly are key.

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Standardized data
entry procedures and processes.

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Stay organized.

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I, you know, being a compulsive,
I think is a key attribute for people

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who are involved in research
because they tend to be

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the ones that want to pay strong attention
to detail.

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Don't get behind because it's
so difficult to get caught back up.

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Easier said than done.

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And then thorough and complete
documentation is key.

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And again,
I provide you some resource websites

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that you an use, as
well as some additional references

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for some of the information
that I provided within the slides.

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You can go to these
and review it in more detail, if you like.

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And so with that, I'd be happy

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to take any questions anyone might have.

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Okay, I'm not seeing any questions,
which is just fine.

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We're right at the end of the time period.

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So I thank you for your attention,
and I think if you come up with questions

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later, there's the opportunity
to send them to me.

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I'll see what I can do to happily answer
those as well I can, or find the

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answers for you. Thank you.