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So, we clearly

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have a lot of challenges
in quality management, in clinical

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research, and, I think, in clinical trials
in particularly.

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We have the issue of the case
report form versus the protocol.

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So, is the case
report form collecting items

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that are not listed in the protocol
to be collected?

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Is the case report form
not allowing us to enter data

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that the protocol says
we need to be collecting?

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We have issues, sometimes,

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with the case report
form in the source document.

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We'll have information on one,
but not the other; they need to match.

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We also may have issues within
the database in the case report form.

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So, the database may not be developed

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in such a way that we can conveniently
get data out

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to analyze in a SPSS or SaaS,

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some type of analysis software program.

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And then, we clearly have,
you know, the whole regulatory compliance

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issues, really understanding
the regulations and understanding

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the guidances which help us to adhere
to the regulations.

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I think sometimes
we don't always remember that

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they're there
and they're intended to help us.

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So, Kleppinger and Ball actually

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came out with an article several years ago
-- it's in the references

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-- that talk about a quality system
components.

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And so, they talk about that
all research personnel

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need to be knowledgeable about regulations

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and about guidances, including ICH GCP,
as well as what internal

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or institutional organizational policies
and SOPs there are.

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And I think that sometimes this

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may not be as stressed in education

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and training for not as much

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the directory search team,
but maybe for direct care nurses

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who might be in an infusion

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unit that are giving an IND product.

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Do they understand what human subjects
protection is all about? Do

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they understand that we have laws around

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clinical research and clinical trials?

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We need to appropriately delegate
responsibilities

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and that does include responsibilities
associated with a license.

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So, who's allowed to dispense medication?

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What's the definition in the state
for dispensing medications?

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And what is going to be the plan
to have coverage?

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Because people go on vacation,
people get sick.

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So, what's that coverage plan
going to look like?

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Do you have policies and procedures?

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Do you have them at an institution level?

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Do you have them at a clinical trials
office level?

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How is the protocol going to be reviewed?

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How are biologic samples
going to be handled?

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What is the data sharing responsibilities
or the data sharing policies?

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How are we maintaining human subjects
protection?

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What is human subjects
protection training look like?

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What are maybe some of the data management
associated responsibilities

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in terms of quality control
and quality assurance?

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And then, what are procedures
for reporting scientific misconduct?

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And then,
do you need to have protocol-specific SOPs

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in a manual of operations,
which can be very helpful,

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especially if you're doing multisite
clinical research studies?

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In terms of training, again,
not just about human

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subjects protection,
but also about GCP, the clinical practice.

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Also, if it's

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an investigational product,
or if there's a particular instrument

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that is being used,
or a specific EKG machine that the sponsor

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has given the site to be used,

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how is training occurring related to that?

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If it's administering
some type of a patient reported outcome,

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some type of a pro tool, are there survey
administration instructions?

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How are people being trained
so that the tool is being administered

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the same way at a site or across sites,

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again, if you have a multisite trial?

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And then,
how are you documenting that training?

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There's also issues

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related to the handling of documents,
standardizing data collection

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through the use of common data elements,

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as well as standard case report forms.

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Also, what are you going to be doing
for archiving?

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So, we have regulatory retention
requirements and certainly within the

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NIH intramural community,
we have NIH policy on records retention.

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So, do we know what those are?

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And what are our SOPs in place to ensure
that we're adhering to those policies?

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And then, how are we securing our files,
whether they be paper or electronic?

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How do we restrict those to only the
appropriate individuals who can see them?

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How does that all occur?

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There's all things to think about, again,
quality management.

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In terms of corrective
and preventive action,

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you want to be able to identify potential
or real problems

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and take action to prevent them
and to fix them.

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So, develop this CAPA plan.

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And you want to be able to document
that whole process because, again,

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it's not meant to be punitive; it's
meant to adhere to our standards

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of excellence related to quality data
and human subjects protection.

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So, ask yourselves
some of these questions.

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Are protocols written clearly

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so that you're not deviating from them,
you can follow them?

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Do you know what
and when procedures to be implemented?

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Are staff checking their own work?

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00:06:32,692 --> 00:06:36,329
Are you relying on someone else to do it?

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I actually had the experience
of having a research nurse coordinator --

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00:06:41,200 --> 00:06:45,271
so, study coordinator who's a nurse
-- actually say that

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that was the sponsor's responsibility

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00:06:47,306 --> 00:06:51,778
to do the monitoring of source document
against case report form.

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And I said, "No, that's really everybody
has responsibility with quality control."

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Does the organization
have a quality management plan,

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00:07:00,787 --> 00:07:06,225
some type of QA plan, monitoring plan,
whatever you want to call it?

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Does the organization
have a way to get a snapshot

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of what's
going on in the area of clinical research?

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Do you have clinical research SOPs?

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How are case report forms developed?

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Is that something that the research team
is responsible

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for, the organization,
or are they generated by the sponsor?

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And do you know what to do

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00:07:31,417 --> 00:07:35,354
if you have a quality inspection
at your site?

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So, if the FDA comes in, do you know

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what your organization's procedures
are is one example.

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So, a few resources.

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The National Institute of Dental
and Craniofacial Research has a toolkit,

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and quality management
is part of that toolkit.

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They have several checklists
available for source documents,

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the regulatory files that I had talked

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about in terms of what to review.

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Also, the NCI has AccrualNet.

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And if you use the search feature
in the upper righthand corner

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and type in "quality management,"
"monitoring," "auditing," you'll get some

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various references to either articles,
or checklists, tools, things like that.

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And then, internationally, the U.K.

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has a clinical trials' toolkit.

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00:08:29,575 --> 00:08:35,081
And if you go to the website and click
the Get Started with the Roadmap,

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you'll see part of their roadmap
is trial management and monitoring.

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00:08:39,118 --> 00:08:43,523
And there are more resources available
if you just search quality management

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in clinical research,

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monitoring, auditing,
and clinical research, or clinical trials.

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And there are a lot of references
out there.

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There's also, if you don't have SOPs,

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there are a lot of SOPs
that seem to be available online.

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You can get a feel for
what might need to be developed

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in a clinical research
organization or a clinical trials' office.