Good Documentation Practice

Transcript

• 00:00Get this recorded so good
• 00:03morning and happy Tuesday.
• 00:06For those who know me and for
• 00:07those who don't, I am Tony too.
• 00:10I am your training and education
• 00:12project manager in the Yale Cancer
• 00:15Center's trial Operation Department.
• 00:18Sarah Ramona has asked that I
• 00:20present today's training on good
• 00:23documentation practices and I'm
• 00:25really excited about this topic.
• 00:28In my prior clinical work,
• 00:31I was the one inspecting the trials in
• 00:34the site binders in preparation for
• 00:37the FDA to be coming in to our office.
• 00:41So I hope that you enjoy the session,
• 00:46and I think we're going to learn a lot today.
• 00:49So our goal is at the end of today's
• 00:52training is for you to understand what
• 00:55are good documentation practices,
• 00:57the importance of capturing
• 01:00documentation and clinical research,
• 01:02how long to keep these records,
• 01:04and what is required when corrections
• 01:07and changes need to be made using
• 01:10the principles of Alcoa plus.
• 01:12And provide you with some source
• 01:15document tation examples to kind of
• 01:17give some further clarification.
• 01:22So what are?
• 01:26Just trying to get my
• 01:27slide to advance, sorry.
• 01:29So what are good documentation practices?
• 01:33Good documentation practices?
• 01:34They offer us a record for our DART teams,
• 01:37auditors, the FDA to review so we can assure
• 01:43our trials are that we I am stuttering.
• 01:47I apologize, this is very early apparently,
• 01:52but it provides our auditors and
• 01:53the FDA so they can review our
• 01:56documents to make sure that we are in
• 01:58compliance with all the applicable.
• 02:00Regulations it provides a snapshot of
• 02:03everything that has happened throughout
• 02:05the lifecycle of the clinical trial,
• 02:08from beginning to end.
• 02:10Failure to maintain adequate records,
• 02:13it's one of the most common violations
• 02:16cited in an FDA warning letters every year.
• 02:19So therefore our documentation must
• 02:21be accurate, concise, legible,
• 02:24traceable, contemporaneous available
• 02:27and accessible and during complete.
• 02:31Consistent,
• 02:32credible and cooperate and we're
• 02:34going to be going through.
• 02:37These Alcoa definitions,
• 02:39later on in our presentation.
• 02:47To understand the importance
• 02:48of good source documentation,
• 02:50we need to review the purpose of
• 02:52good documentation practices.
• 02:54There are a key principles in the ICHGCP.
• 02:59It's being able to reconstruct the
• 03:02clinical trial as it happened.
• 03:04The importance of being able to
• 03:07do that is to make sure that our
• 03:10clinical data and our subjects
• 03:13safety are maintained at all times.
• 03:16It's accountability of our investigational
• 03:19of our investigational product.
• 03:22Accountability of subject recruitment,
• 03:24enrollment and participation.
• 03:32In research, the only thing that we can
• 03:34test to our efforts is the documentation.
• 03:37The Golden rule is if it.
• 03:39If it's not documented, it never happened,
• 03:42and that's very important.
• 03:44One of an inspection that we had.
• 03:48The inspector says we know
• 03:50that you have two meetings,
• 03:51but you're not capturing it.
• 03:53Where are your meeting notes?
• 03:55That was a huge red flag that we
• 03:57had to get resolved immediately,
• 04:00so it's it's remembering to
• 04:03document pretty much everything,
• 04:04anything and everything that happens on
• 04:07a clinical trial that may be needed in
• 04:09the future to tell the complete story
• 04:12of that clinical trial from beginning to end.
• 04:15This includes saving essential
• 04:18email correspondences.
• 04:19Between the sponsor,
• 04:20the site staff,
• 04:22the clinical research associate
• 04:24monitors the PII.
• 04:26The list goes on.
• 04:28If we don't save these email
• 04:30correspondence and we have to go back
• 04:33and trying to figure out what happened,
• 04:35that's the missing piece of the puzzle that
• 04:38we need to kind of clarify what happened.
• 04:41So we have to be able to
• 04:43document and explain.
• 04:44So when someone reads what is happening now,
• 04:47510, fifteen, 20 years from now.
• 04:50They know what is happening today.
• 04:54I also want to remind that email
• 04:57correspondence they can be audited.
• 04:59They can be used in a court of law
• 05:01as well as requested by the IRB.
• 05:04I had a study that the we
• 05:07received an amendment about six
• 05:09months late from the sponsor.
• 05:11It involved risk changes that
• 05:14was impacting subject safety.
• 05:17The IRB requested to see the email
• 05:20correspondence to show when we received them.
• 05:23From the sponsor.
• 05:25The amendment was submitted
• 05:26within 30 days of receiving
• 05:28the amendment from the sponsor,
• 05:31but the sponsor was late by six months,
• 05:34getting it to us.
• 05:42Here are some examples of some email
• 05:45correspondence is what should we say?
• 05:47What should not be saved?
• 05:48That is a very frequent question
• 05:50that pops up the letter on the
• 05:53left is about an SAE for our site
• 05:57about hyperthyroidism Grade 3 and
• 06:00being related within an attachment.
• 06:03So that should be, say,
• 06:05email correspondence on the right.
• 06:08It's basically asking and informing
• 06:11the monitors here on site and if
• 06:14they can enter time in the database
• 06:17and pick up the time later.
• 06:19That's something that doesn't
• 06:20need to be saved.
• 06:21That says that doesn't
• 06:24pertain to the protocol.
• 06:26The other thing when we're looking
• 06:28at email correspondences is to be
• 06:31able to read the email communication
• 06:34thoroughly and make sure that it's.
• 06:37That nothing inappropriate is in the email.
• 06:41If need be,
• 06:42reach out to the person and let them
• 06:44know that you're going to be sending
• 06:47them another email that they need to
• 06:49reply to because the first response
• 06:52that they provided us contains
• 06:55something that shouldn't be in there.
• 06:57I was talking with Sarah about this
• 06:59last week on the sponsor side when
• 07:01I worked when I was doing an audit,
• 07:04I was looking at the site communications
• 07:06and I came across and reading the email.
• 07:09The email contained pertinent information
• 07:11about the protocol and the sign,
• 07:13but in there it captured language
• 07:17between the study coordinator and
• 07:20PII about going out to dinner and
• 07:22dating and that obviously should not
• 07:25have been piled in the site Binder.
• 07:28So you really need to be able to go
• 07:31through and read and make sure what
• 07:33we are going to file is appropriate.
• 07:42Types of the relevant regulatory email
• 07:46correspondences that we should be saving.
• 07:50Is when the trial status changes
• 07:52when we go to open to accrual,
• 07:55when we go from open to accrual,
• 07:57to close to accrual,
• 07:59or when the study is suspended or terminated,
• 08:01we need to be able to keep those records.
• 08:04The sponsor NPI communications agendas,
• 08:08meetings, telephone call reports,
• 08:11agreements between organizations,
• 08:13and people that impact the study.
• 08:17Protocol violations and
• 08:19adverse event reporting.
• 08:23Communications with our medical
• 08:26monitors about an example of a
• 08:29subject that's not that's ineligible,
• 08:31but we're going to allow to continue
• 08:34to participate on the clinical trial.
• 08:37Those are key factors that we need
• 08:39to be able to document and be able
• 08:42to explain and tell the whole story.
• 08:44All these different points.
• 08:52Source data and source documents.
• 08:56Source documents are or the
• 08:58original documents or the data and
• 09:01records in electronic database.
• 09:03All the information and the records.
• 09:06Are certified copies of the original
• 09:09records of clinical findings, observations,
• 09:11or other activities in a clinical
• 09:14trial necessary for the reconstruction
• 09:17and reevaluation of the trial?
• 09:20So when we talk about source documents,
• 09:22just keep in mind it's the original document.
• 09:29Here on the right are examples of source
• 09:33documents for the ICHGCPE 6 regulations,
• 09:36subject files, subject Diaries,
• 09:39lab Notes, hospital records,
• 09:42patient questionnaires,
• 09:44the pharmacy dispensing records,
• 09:47all of this we have to make sure that we
• 09:51are using good documentation practices
• 09:54and maintaining these source documents.
• 09:57Records and reports the PII needs to
• 10:01ensure the accuracy, the legibility,
• 10:04the completeness and timeliness of the
• 10:06data reported to the sponsor in the case.
• 10:09Report forms and all other required reports.
• 10:13Data reported on the CRF that are
• 10:16derived from source documents should be
• 10:18consistent with the source documents or
• 10:21the discrepancies we need to be able to
• 10:24explain that if there is a change to the CRF,
• 10:28we need to make sure that we're
• 10:31following good documentation practices
• 10:33and making sure that the corrections
• 10:37were being able to date.
• 10:39When the correction is made, initial,
• 10:41explain why a correction was made.
• 10:44Making sure that the original entry we
• 10:47can still read through the correction.
• 10:49And has to be able to be audited
• 10:53and to be able to to explain the
• 10:56difference between the original
• 10:58entry and the correction.
• 11:05Note to files. No to files are
• 11:09allowed in clinical research.
• 11:11We just need to be very careful and
• 11:13cautious that we don't use too many
• 11:16notice files on a clinical trial,
• 11:18because that can raise a red flag
• 11:21to an inspector when auditor that
• 11:23something here is just not right or
• 11:26going on and then they start to dig a
• 11:30little bit further to find out more.
• 11:33If there's something else that they
• 11:35need to be looking at for findings.
• 11:37It's also not a replacement or substitute
• 11:40for notifying the IRB or notify Isles.
• 11:43It should allow us to document
• 11:45and clarify an error omission.
• 11:48A discrepancy in the research to
• 11:50document a problem or corrective action.
• 11:56When we do the note to files,
• 11:58it should include the root cause.
• 12:01The Kappa plan is the Kappa plan.
• 12:05Did it resolve the discrepancy in the issue?
• 12:10And where should we be filing these
• 12:12note to files if it's steady related,
• 12:14it needs to go in the study
• 12:16Binder where it's relevant to.
• 12:18If it's related to a study participant,
• 12:21then it should go with the
• 12:23participant study records.
• 12:31Here again, it's covering when to
• 12:33use and not to use a note to file.
• 12:36We cannot emphasize this enough.
• 12:40So. To use a note to file,
• 12:43its to clarify or add additional information.
• 12:47It might be clarifying why
• 12:49a subject was out of window.
• 12:53Clarifying information related
• 12:55to the source documents.
• 12:57It's record any discrepancy that
• 12:59applies to a single participant
• 13:02or multiple participants that are
• 13:04participating in a clinical trial.
• 13:10Again, when not to use a note to file,
• 13:13we don't use it as a replacement
• 13:16for notifying the IRB.
• 13:18And we don't use it for adverse
• 13:20or serious adverse events.
• 13:24An example of a note to file.
• 13:27This one is talking about that there
• 13:29was a clinical research personnel
• 13:32that was participating on a study.
• 13:36And was added to this trial,
• 13:38but was added in error.
• 13:41And then they're going to
• 13:43be removed off of the DOA.
• 13:48So in this example, this is very
• 13:51appropriate to have a note to
• 13:53file to explain that discrepancy.
• 13:58Clinical trial documents that we need
• 14:00to be making sure that we're paying
• 14:03attention to for our good documentation
• 14:05practices is our pre study activities,
• 14:07site selection communication feasibility.
• 14:11Why a site may not or should be feasible
• 14:17to participate meeting minutes?
• 14:20Study initiation the DOA.
• 14:25Review of the protocol.
• 14:27Our training activities making
• 14:30sure that we are capturing and
• 14:33filing and documenting the city,
• 14:36training the medical licenses,
• 14:39the Protocol Pacific training.
• 14:41I'm reading of the particular asopis.
• 14:43All of that needs to be
• 14:45maintained and documented.
• 14:46Using good documentation practices.
• 14:49Communication with the subject.
• 14:51The sponsor, the IRB,
• 14:53the FDA informed consent process.
• 14:56Individual documentation for all
• 14:59subjects and protocol activities.
• 15:04At first events serious adverse events,
• 15:07unanticipated problems, deviations.
• 15:10When deviations are happening,
• 15:14we should be asking ourselves
• 15:16should the protocol be amended.
• 15:18Should the aesopi be revised?
• 15:23With deviations we need to make
• 15:26sure that we're smoothing according
• 15:28to the IRB reporting timelines.
• 15:31The Protocol and regulatory deviations
• 15:34we need to be making sure that we're
• 15:38really looking at at that thoroughly.
• 15:41The P needs to assess the reason for
• 15:44the deviation in real time and assess
• 15:47the potential risk to participants.
• 15:51Corrective and preventive action plans.
• 15:53Being able to capture the
• 15:56deviation from reoccurring.
• 15:57Documenting the implementation of the
• 16:00Kappa and remember to follow up on.
• 16:05One thing when we were looking
• 16:08at deviations is when something
• 16:10is reported is to kind of take a
• 16:13wider scope and determine was it
• 16:16only one patient that was impacted,
• 16:18or were there there other patients
• 16:21or subjects that were impacted on
• 16:23the clinical trial? As well as.
• 16:26Could this event?
• 16:27Is it also occurring on additional
• 16:30clinical trials?
• 16:31So those are questions that we need
• 16:33to be asking in regulatory when we are
• 16:36reviewing deviations and reporting.
• 16:43Documentation of PII oversight
• 16:46with the ES este ES and the
• 16:50anticipated problems is reviewing
• 16:52the eligibility criteria,
• 16:54review of lab and other protocol procedures.
• 16:57Results subject accountability,
• 16:59enrollment logs.
• 17:03Drug Accountability progress notes.
• 17:05Review of case report forms.
• 17:09Documentation of sponsor
• 17:11investigator over sign.
• 17:13Monitoring the responsibilities
• 17:14and communication with other sites.
• 17:21Our good documentation practices always use
• 17:25if it's in a paper form and we're using.
• 17:30Always use an ink pad.
• 17:33Black and Blues preferred.
• 17:36Try to always avoid or never use gel pens,
• 17:39or with erasable ink.
• 17:41Never used whiteout or corrective
• 17:44tape for corrections if you
• 17:46do need to make a correction,
• 17:48you need to make sure that we're following.
• 17:56Being able to.
• 17:58Do a strikethrough through the error
• 18:01in making a note and initialing
• 18:05and dating it for the correction.
• 18:10We need to make sure that we're
• 18:12signing initialing dating entries
• 18:13at the time that they're made.
• 18:17So that way those entries are
• 18:20contemporaneous date entries
• 18:22must be signed or initialed by
• 18:24the person entering the data.
• 18:26And interest must remain legible.
• 18:30Don't go back and post or pre
• 18:32date don't keep any blank spaces.
• 18:35If there's a space on the form
• 18:37that needs to be completed.
• 18:39It needs to go ahead and be
• 18:41completed in that field.
• 18:42Don't use Ditto symbols.
• 18:44Never use pencils.
• 18:48And most important, don't use sticky
• 18:50notes to record data or information.
• 18:54One of the sites that I was auditing
• 18:56on I came across multiple sticky
• 18:59notes throughout the clinical
• 19:01trial and you know, I was.
• 19:03I was pulling, you know,
• 19:04the sticky note off at the the documents.
• 19:06Like why does this in reference
• 19:09to who wrote it?
• 19:10No one could could answer or explain it.
• 19:14Those bring up red flags
• 19:15and an audit situation.
• 19:17Those are things that we
• 19:18don't want to be able.
• 19:22To be in a pickle with the FDA.
• 19:28So for good documentation practices
• 19:30we use a term called ECHO Applause.
• 19:33So for Alcoa its meaning its attributable,
• 19:37legible, contemporaneous,
• 19:39original, accurate, complete,
• 19:42consistent, enduring in. Available.
• 19:48If we follow these sets of
• 19:51good documentation practices,
• 19:52that can make sure that.
• 19:54We aren't creating things and entering
• 19:57things on time when they should be.
• 20:00We're making sure that it's
• 20:03attributable and identifiable to
• 20:04the person that recorded the data.
• 20:06So when we look at a document or data entry,
• 20:10we should be able to tie it back
• 20:12to the person that created that
• 20:14document or created that entry.
• 20:20So we need to make sure that
• 20:23overall it's attributable
• 20:25dates and document versions.
• 20:27Make sure that for dates
• 20:29we include the full year.
• 20:31We don't want to use a partial year.
• 20:34It was when we switched over to
• 20:392021. I remember last year there was no.
• 20:44Don't just use like.
• 20:46Ten 12:20 if someone could go back
• 20:49and fill in the last two years
• 20:52of making it maybe 2019 or 2018,
• 20:55when actually it's 2021. So.
• 21:00We do have a set clear form
• 21:02and how dates are formatted,
• 21:05making sure that there are version dates
• 21:07and numbers in the document footers.
• 21:09That's important,
• 21:10so our clinical research team.
• 21:12We know which protocol version.
• 21:14Which consent version that
• 21:15we are working off that.
• 21:17So there is no confusion.
• 21:21Examples of incorrect written dates.
• 21:25The top example here is a mixture of
• 21:27written and typed dates and all the
• 21:30dates are have a sequential order.
• 21:33In the bottom example,
• 21:35the end date is not legible.
• 21:38Is that? 930 eighteen.
• 21:42Is that a seven? Is it a four?
• 21:46I can't make out the month.
• 21:48And then the bottom the PRI
• 21:50initialed for a no date on a DOA.
• 21:55So those were things that would have
• 21:58to be explained in an audit situation.
• 22:04Can you sign for the P?
• 22:07No, you can't sign for the Pi.
• 22:09No one can sign for the Pi if you if someone
• 22:13asks you that you need to tell them no.
• 22:16Only the Pi can sign for themselves.
• 22:19I actually had a study coordinator
• 22:21reached out to me wanting to complete
• 22:24the Pi city training on his behalf
• 22:27because the Pi was on vacation.
• 22:29And I was like, no,
• 22:31we cannot do that.
• 22:33They asked if they could change
• 22:36the training to the piece personal
• 22:38email address and we came back
• 22:40and said no because with his IWRS
• 22:43account and everything else that
• 22:45was setting up for the training,
• 22:47it had to be 1 consistent
• 22:49email which was his work email.
• 22:56The P though, can delegate appropriate
• 22:59task to study team members.
• 23:02In order to do that,
• 23:04the P is going to make sure that they
• 23:07are trained and they are appropriate
• 23:09for this task to be delegated to,
• 23:13though when that happens you must
• 23:15sign your own name, not the PI's name.
• 23:19And if you're not delegated to do something.
• 23:23You should not be doing it.
• 23:29When we're working with good
• 23:31documentation practices,
• 23:32we need to make sure things are legible.
• 23:34That means that we're able to read it.
• 23:37Clearly, it's preserved.
• 23:39It's recorded in a durable way.
• 23:43Entries should not be obscured.
• 23:46We're going to use a strikethrough
• 23:48with a single line, initial date,
• 23:50and add an explanation if needed.
• 23:54Here are examples of.
• 23:57Corrections.
• 23:58Got earned, not legible.
• 24:03If we're reading in the top example.
• 24:07There aren't reasons why there's
• 24:10a cross through. And I can not
• 24:13sure what the year dates are.
• 24:18And it looks like maybe there is a reason,
• 24:20but I'm really not quite sure what
• 24:22that entry is in this example here.
• 24:27In the bottom bottom example,
• 24:30the resident the regulatory designate
• 24:32typed in a date into the DOA page.
• 24:35There's not an initial update
• 24:37with correction change,
• 24:38it's a scan. Document,
• 24:40which also down here at the bottom.
• 24:44And cut off the PI's initials
• 24:47for the study in dates.
• 24:49So if you are scanning a document
• 24:51in to a permanent record,
• 24:53you need to double check that the
• 24:55scan does not cut off the document.
• 25:02In this example of how to make a correction?
• 25:06Up here in the green circle.
• 25:09The original entry they only
• 25:12put in a partial year of 21.
• 25:15So they corrected it.
• 25:17By adding 2021 and with the explanation
• 25:20that they added the full year,
• 25:23they initialed it and they dated the
• 25:25day that they made the correction.
• 25:28They made the correction on the same day.
• 25:37Contemporaneous
• 25:40it needs to be happening at the same time.
• 25:45Recorded like in the same day,
• 25:48within a few minutes.
• 25:49We're not going to be doing
• 25:51those entries like 2 weeks later.
• 25:56So for physicians cosigns on clinic notes,
• 26:01this should be happening within 24 hours.
• 26:10Here is an example of where
• 26:13contemporaneous was not being followed.
• 26:16We have the Pi where they
• 26:18drew a line through initially.
• 26:20What should have been happening
• 26:23is the Pi initially on the DOA.
• 26:27In a timely manner and initialing
• 26:30by each person's name.
• 26:31So if each of these persons was.
• 26:34Added. On these days,
• 26:36that's when the Pi should be initialing.
• 26:42And then we have at the bottom example
• 26:44the Pi went ahead and signed off
• 26:46on the DOA before the study ended.
• 26:51That's a huge discrepancy.
• 26:55How can you sign off?
• 26:57If the study is still ongoing,
• 27:00those are things that when we see,
• 27:02you need to be asking yourself.
• 27:11So what does contemporaneous mean
• 27:13for us for our for our office?
• 27:15It needs timely entry at the CRC
• 27:18CRA in clinic notes, the Physician
• 27:21Coast signature on the clinic notes.
• 27:26He has signatures on labs.
• 27:28Adverse events tumor loss.
• 27:31Deal ways the 1572.
• 27:33Study team signatures on
• 27:34training us to CAITIANS and
• 27:37review the Ind safety report.
• 27:42At the bottom are items that our
• 27:44monitors have brought to our attention.
• 27:49So in the first example here,
• 27:51for staff qualifications and training,
• 27:54it was noted that the signatures
• 27:57acknowledging the updated protocol
• 27:59training was not contemporaneous.
• 28:02There were several investigators
• 28:03who signed more than one version
• 28:06of the Protocol on the same day,
• 28:08but the protocols were approved
• 28:10roughly 3 months apart.
• 28:15In the bottom example,
• 28:17it's noted that the research project,
• 28:19the Research Nurse Progress notes
• 28:22have not been cosigned by the treating
• 28:25investigator in a timely manner.
• 28:28As a result, cannot confirm
• 28:30contemporaneous review,
• 28:31CONMED and toxicity assessment
• 28:34recorded in these notes.
• 28:42Documentation and we need to make
• 28:44sure that it is original that this is
• 28:47the first time something is written.
• 28:49If we transfer nodes to another document.
• 28:53The new source is not the original.
• 28:57Taking notes in a clinic and
• 28:59transferring them to the CRC.
• 29:02CRC note and epic. Allowances
• 29:05can be made for certified copies.
• 29:13Accurate all records need to be accurate.
• 29:17We need to avoid documenting in
• 29:20multiple places if it's not necessary.
• 29:24A source documents not truly
• 29:27considered accurate unless it
• 29:29adheres to other Alcoa principles.
• 29:31We also need to make sure that
• 29:34we are consistent if multiple
• 29:36documents record the same data,
• 29:38they should all agree.
• 29:41And it should also reflect
• 29:43what has truly happened.
• 29:48So we have our KOA and then we have the plot.
• 29:51The plus means complete,
• 29:54consistent and during and available.
• 29:58That's the way that we stored
• 30:01the information recorded.
• 30:04It allows this information to be able
• 30:07to be accurate in its reporting and
• 30:11and interpretation and verification.
• 30:17Complete all records should have
• 30:18an audit trail to show that
• 30:21nothing has been deleted or lost.
• 30:23Again, ten 1520 years from now we should
• 30:25be able to piece together everything
• 30:28that has happened today and in the past.
• 30:31Telling a full story on the clinical
• 30:33trial as well as the subjects
• 30:35participation in the clinical trial.
• 30:37Consistent or are all elements
• 30:41in chronological order?
• 30:43In during making sure that the
• 30:46records exist for the entire period.
• 30:49And being available,
• 30:50can the data be accessed for review
• 30:52over the lifetime of a record?
• 30:59Examples of good documentation
• 31:02practices using Alcoa?
• 31:04We have a strikethrough,
• 31:06the note with it being completed.
• 31:08We have the initial JS with the
• 31:11date that the correction was made.
• 31:19For data transmission methods documentation.
• 31:22If you get information from a conversation
• 31:26or or mobile heartbeat need to
• 31:30document the conversation took place.
• 31:33We should only be using approved
• 31:35methods for personal health information
• 31:38transmission using your personal cell phone.
• 31:42To tax. Is not an approved method.
• 31:49Record storage maintenance and retention.
• 31:55For the FDA, we need to be able
• 31:57to keep records for two years.
• 32:00HIPAA, the six years HSS is 3 years I CHG CP.
• 32:07We need to be keeping records
• 32:09for two years and the sponsor
• 32:11has their requirements there.
• 32:14But we need to make sure that we
• 32:16implement administrative, physical,
• 32:17and technical safeguards that
• 32:19are reasonable and appropriately
• 32:22protect the confidentiality,
• 32:24integrity and availability of
• 32:26electronic protected health
• 32:28information that it creates.
• 32:30Receives, maintains or transmits.
• 32:34Keeping information making sure that
• 32:36the cabinets are kept law limiting
• 32:39access to those who truly need
• 32:41to have access and making sure.
• 32:44Password protection on electronic systems.
• 32:52For the electronic records and electronic
• 32:55signatures or eras regulation for compliance.
• 32:58In March 1997, the FDA issued final part
• 33:0311 regulations that provide criteria
• 33:06for acceptance by the FDA under certain
• 33:10circumstances of electronic records,
• 33:12electronic signatures and
• 33:15handwritten signatures.
• 33:17Two electronic records as equivalent
• 33:20to paper records and handwritten
• 33:23signatures executed on paper.
• 33:25These regulations,
• 33:26which apply to all FDA program areas,
• 33:29were intended to permit the widest
• 33:32possible use of electronic technology
• 33:34compatible with the FDA's responsibility
• 33:37to protect the public health.
• 33:40So what is 21 CRF part 11?
• 33:45It's the code for federal regulation.
• 33:48It details the criteria under which
• 33:51electronic records and signatures
• 33:53are considered to be trustworthy
• 33:56and equivalent to paper records.
• 33:58The electronic records,
• 33:59a combination of text,
• 34:01graphic data, pictorial,
• 34:03audio and other information represented
• 34:06in digital form that is created,
• 34:09modified, maintain,
• 34:10archive, retrieve,
• 34:11or distributed by a computer system.
• 34:15The electronic signature is a
• 34:18computer data compilation of any
• 34:21symbol or series of symbols executed,
• 34:23adopted or authorized by an individual
• 34:26to the legal binding equivalent of
• 34:29the individuals handwritten signature.
• 34:34For electronic records.
• 34:39At least as secure as paper,
• 34:42we need to maintain the
• 34:44data security and integrity.
• 34:46Making sure it's reliable,
• 34:48the software is validated.
• 34:51Being able to copy and
• 34:53retrieve and control access,
• 34:55making sure that timestamp and audit
• 34:58trails in the electronic records,
• 35:01training ESO peas,
• 35:03Epic erect training.
• 35:06We still need to make sure
• 35:07that we're following the good
• 35:09documentation practices.
• 35:13Translated documents,
• 35:14documents that are translated into
• 35:16other languages also follow the good.
• 35:19The same good documentation practices
• 35:21we need to make sure they're
• 35:24organized and identify attaining
• 35:26the translation certificates.
• 35:28Examples of these documents that
• 35:30would be need to be translated,
• 35:33informed consents.
• 35:35Hip US subject questionaries subject Diaries.
• 35:39All subject materials and marketing
• 35:42materials we need to make sure
• 35:45that we have the translation
• 35:47certificates for those documents.
• 35:52Making sure that these documents
• 35:54are organized and identified and
• 35:56detained so they correspond with
• 35:59the translation certificates.
• 36:05In summary, all study related documents.
• 36:09Documentation whether it be pepper,
• 36:11paper or electronic should be organized,
• 36:14identified and retained so it
• 36:17can be accurately understood
• 36:18by an independent reviewer.
• 36:21Can I reconstruct what happened?
• 36:23Can identify who did what,
• 36:25when and where?
• 36:27Am I confident in the accuracy and
• 36:30authenticity of the research data?
• 36:33Without the documentation,
• 36:35there is no research.
• 36:38Our records should be able to tell the
• 36:41complete story of the study on its own.
• 36:46We need to make sure that we
• 36:49maintain adequate records.
• 36:50The source documentation is where
• 36:53the information is first recorded.
• 36:55Making sure that the data is,
• 36:57we can verify it and we can
• 37:00follow an audit trail using
• 37:02the Alcoa plus principles.
• 37:05Corrections to source documents,
• 37:07making sure that we draw a line
• 37:10through those corrections we date it,
• 37:13initial it and provide the
• 37:15reason for the correction.
• 37:20So in review. Alcoa means
• 37:27AB or CA is accurate
• 37:31attributable contemporaneous.
• 37:33Legible original.
• 37:36Be attributable, legible,
• 37:38correct, original and accurate
• 37:40or C attributable legible,
• 37:43contemporaneous original and appropriate.
• 37:46If you can provide your answers in the chat.
• 37:52We'll see what our group majority
• 37:55thinks what is correct for number 1?
• 38:10We have some answers coming
• 38:12and see you are correct.
• 38:15Thank you Briana and Ashley and
• 38:19Stephanie for for sharing your answers.
• 38:23And two is good documentation practice.
• 38:26In good documentation,
• 38:28practice contemporary,
• 38:29contemporaneous means the data
• 38:31was recorded at the time the
• 38:33observation was made and the
• 38:36associated signature date confirmed.
• 38:38This is this true or false?
• 38:49You are correct, it would be true.
• 38:53Just gonna move that over there.
• 38:56#3I CHG CP defines source
• 38:59document as a hospital records.
• 39:02Clinical charts and webnotes
• 39:04subject Diaries and files.
• 39:06Pharmacy records and diagnosis.
• 39:08Test results or all of the above. Or EA&C.
• 39:15What do you guys think the answer is?
• 39:24Day that is correct all above.
• 39:28Electronic records must be a be a
• 39:31secured as paper records be use validate,
• 39:34assistance with audit trails.
• 39:36CB supportive with training and ESO
• 39:39peas D all of the above or E8 and B.
• 39:49So why do you guys think
• 39:51electronic records must be?
• 40:03Yes day again.
• 40:06And our last question records
• 40:08must be retained for two years if
• 40:11HIPAA authorizations are obtained.
• 40:13Is that true or false?
• 40:30The answer is actually false for that.
• 40:40Does anyone remember the how many years
• 40:42that you need to keep those records?
• 40:56I believe there that it was three
• 40:59years I'm trying to go back to
• 41:01that slide to a pull up for you.
• 41:23There it is. Slide 35.
• 41:29Oh, I was wrong six years.
• 41:40OK.
• 41:47OK. Well, at this point I do want to
• 41:51open up for discussion or for questions.
• 42:29I'm not quite sure where this
• 42:32presentation is going to be saved at yet.
• 42:34I will follow up with Sarah
• 42:37where it's going to be.
• 42:39Doing this presentation with
• 42:41another group on Thursday,
• 42:43which will also be reported.
• 42:44So between the two recordings.
• 42:49We're gonna save the the better one,
• 42:51and I apologize for coughing.
• 42:52I have seemed to have caught
• 42:54my daughter's head cold.
• 43:05Well, if no one has any questions
• 43:07about good documentation practice,
• 43:09you can follow up with me,
• 43:11your regulatory manager.
• 43:14If you have further questions,
• 43:16I appreciate everyone's time in
• 43:19today's training and I look forward
• 43:22to talking to you guys later.
• 43:24Enjoy the rest of your morning. Bye.