Staff Agenda Item Expectations Time
All Research
En-
vironments
Noted deficiencies, chal-
lenges, or needs
observed in
administrative, patient,
and processing areas at
all cam- puses.
5
min-
utes
Nitasha-
none LaToya-
none Colette-
none Will-
none
Cynthia-
none
Priyanka- her computer
keeps on crashing and isn’t
able to handle big data,
Crystee recom- mends
Priyanka to forward the
email/notes from STATA to
her requesting for 64 bit.
Vaidehi- Given the big data,
un- able to open in excel.
Need to come up with a
cloud base, which has more
accessibility and ability to
delegate who has rights.
Crystee advises for that
request to be emailed to
her.
Crystee mentions that we
are more likely to go with
SAS in the future.
Crystee- none
All Equipment/
S
upplies/Rec
or ds
Noted deficiencies,
chal- lenges, or needs
related to MHS and
sponsor-owned
equipment; records,
office and medical
supplies.
5
min-
utes
Nitasha- needs to order
binders for regulatory
purposes, Crystee advises to
check what supplies Cynthia
and Colette have in their
office & to order needed as
ac- cordingly
LaToya- binders are needed
due to lack of. Crystee
suggests that we ask the
sponsor for binder supply.
Will have sponsor send the
request to CRAs.
Colette-none
Will-none
Cynthia- none
Pryianka-
none
Vaidehi- tabs/dividers,
Crystee advises that there
are plenty of dividers
available in the cabi- nets.
Crystee- none, but please
don’t wait until close to or
on the 10 of the month to
give Daryl supply orders.
Coordinators have been
getting medical supplies as
well.
Staff Agenda Item Expectations Time
Cryste
e
LaToy
a
Vaide
hi
Staffing
Plans
A 4-week review of
upcoming PTO,
conferences, and on-
call/mentor assignments.
5
min-
utes
LaToya- 3/27- Keaton Out
on PTO
3/29 Esme M PTO
3/30- Seena Esme C & M
PTO 4/2- Seena PTO
4/4- Keaton late arrival
4/6- Keaton & Shandra
PTO No ETA for Melba,
LaToya will follow up with
her.
On call this week-Esme M,
Shandra will take E2’s
place on Friday.
Vaidehi- 3/23 Brittany
unsched- uled PTO
4/3 Vaidehi
Conference 9/07/2018,
on site/single day.
Crystee- 3/30 Cynthia,
Nitasha, Will PTO
4/3-
Vaidehi
4/27-
Colette
Staff Agenda Item Expectations Time
Natash
a
Cynthi
a
Colette
Industry
En-
gagement
A 4-week review of
upcoming
PSSV/SIV/MV/Training
schedule. This also
includes review of follow-
up letters and
outstanding items re-
lated to upcoming
events.
10
min-
utes
Nitasha- 2 new protocols
that are coming up
(Mansfield & DNP students -
College projects so she’s
going to hand it over to
Tonya. Monitoring visiting
April will be scheduled, still
working with PI. Submitted
approvals to Crystee. Tonya
is currently work- ing with
PNG, Crystee will follow up
with Tonya.
Colette- 4/4 closeout visit
with Theravance 0112, full
event and will be on both
sides of office.
CRA will be here, Colette will
take him to MCMC,
pharmacy on Dallas campus,
CRI to look at regulatory
binders, have the de-
briefing. Dr Akins will be at
MDMC, Colette will confirm
that Dr. Akins will be present
at the meeting.
4/5 SIV, invite already sent -
Co- lette will send a
reminder again 4/10 & 4/11-
monitoring visit for Gilead
1943 & 1944
4/19-Conatus visit
Vaidehi inquires how TXA
com- ponents should be
handled.
Crystee advises once all of
them identified, send
Colette an email with all
those emails attached.
Cynthia- 4/2 & 4/3 GINFIT
4/3 & 4/4 Gilead 4024 &
4025 4/5 site
management call with E2
for Gilead 4022
4/12- closeout visit for
Gilead 4022
4/16- monitoring vist for
Intercept 747303
All summary letters in binder
have been reviewed,
question- naires weren’t
completed or sub- mitted on
time.
Gilead 1944- Page 7 is
missing, Dr. Mantry has
already signed & reported
to CRA.
Natasha MHSCRI En- A 4-week review of
upcoming
5 min- None given
Staff Agenda Item Expectations Time
Tonya gagement CRI MV/Training
schedule. This also
includes a review of
summary letters and out-
standing items related to
up- coming events.
utes
Natash
a
Cynthi
a
Colette
IRB A review of pending
submis- sions,
determination letters,
and CAPAs.
10
min-
utes
Nitasha- none given
Colette- submitted continual
re- view for Boston Scientific
Wallflex, did receive
approval for Conatus ICF.
Working this week on
continual review for Gilead
4063 and Octeta Cirius (Dr.
Barnes NASH Study)
Cynthia- IRB pending
approval for BEAT-HF sign
off the IAA. Dr. Williams has
completed his CITI training.
Cynthia will go to get his
signature on the delega-
tion log. Pending IRB
approval is for GENFIT
Protocol for Devia- tion for
Melba not being on the
delegation log. Crystee
reminds that Dr. Williams is
Dr. Horne’s designated
surgeon for Horne’s
Edwards Life Sciences
Study, and that he is
required to com- plete the
HSR and GCP (all PIs are
required to)
Will Finances A historical review of
produc- tivity and YTD
revenue.
5
min-
utes
Will Ren shared the CRC pro-
ductivity report (below) that
summarizes patient encounters
as of 03/ /2018 at noon.
LaToya inquired if Will
counted pre-screens as
appointment days. LaToya
asked would it be feasible to
have a 4th chart.
Crystee informs that the
amount of time it takes for pre
screen needs to be managed in-
dividually.
Crystee mentions that
Priyanka Varma and Keaton
White need to increase their
productivity percentages. Also,
Will need to close out activities
on Monday
Staff Agenda Item Expectations Time
since he will be absent Friday.
The Price is Right will be on
April 5, 2018 in the afternoon.
LaToya
Colette
Priyanka
A.
Quality
As-
surance
A review of the MHSCRI
QAPI Plan and related
activi- ties.
10
min-
utes
None given
Staff Agenda Item Expectations Time
All OPEN MIC An opportunity to
discuss all other items
(if time permits).
5
min-
utes
Nitasha- inquired about her
PTO request, Crystee will
look at it, and reply to her
today.
LaToya- BMS 068, 069
Feasibil- ity Questionaire
regarding the Dexa scan,
during the PSSV call on 3/26
it is now a required scan.
LaToya asks is another CTA
thats needed to use ad-
vanced imaging. Legal is not
willing to due to the
relationship with Methodist
and NDI. Crystee
recommends she sets up a
meeting her and LaToya,
Janet and Dr. Mantry.
LaToya asks: Is there a
way to revise archiving for
Epic to re- move the
subject, once the binder in
the back has been pulled.
Crystee - advises that Will
will contact Abbvie
employee, Leona Abt on
getting invoices so we can
get paid and get the binders
out of LaToya’s office.April
6th is the target for AbbVie
999 to be done. Crystee
recommends reg- ulatory
binders to be brought to her
office as a reminder for her
to remind CRI staff. April 6 is
the target date for AbbVie
999 to be done.
Colette- going to bring folder
re- garding George Michael
Jenkins, MD.
Priyanka- anytime theres a
SIV update, let her know
Colette asks about Dr.
Cooper’s race is asked,
those who wanted to discuss
stayed.
