Clinical Trials Office Submission Process presented by by Sus - - PowerPoint PPT Presentation

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Clinical Trials Office Submission Process presented by by Sus - - PowerPoint PPT Presentation

Nov 08, 2023 175 likes •347 views

Clinical Trials Office Submission Process presented by by Sus Susan Sw Swit itz - CTO Suppor ort A Assistant Susan.S .Swi witz tz@uch.e h.edu du 720 720-848 848-7168 7168 TO: 3 rd rd Floor Lepri Ou Outpa patien ent C CTO: r

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SLIDE 1

Clinical Trials Office Submission Process

presented by by Sus Susan Sw Swit itz

  • CTO Suppor
  • rt A

Assistant Susan.S .Swi witz tz@uch.e h.edu du 720 720-848 848-7168 7168

Ou Outpa patien ent C CTO: TO: 3rd

rd Floor Lepri

r Leprino Building Inp npatie tient nt C CTO : : 12th

th Floor A

r Anschu chutz Inpat atient P Pavi avilion / / 12E

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SLIDE 2

CTO A Admin inistr istratio tion

Dr.

  • r. Thoma

mas Camp mpbell ll Medic ical D l Dire irector Di Diane Branham, RN RN, , BSN SN , , MBA Clinic linical N l Nurs rsin ing D Dire irector Joni Do Donahoo, N NP, , DN DNP CT CTRC I C IP P Nurse Manager Timothy Wo Woodworth, M MSW, SW, M MBA CT CTRC O C OP P Manager

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SLIDE 3

Is my study a a clin inic ical t l trial?

Your ur proto tocol l mus must m t meet tw t two c crite iteria ia to go go t thro hrough t the C he CTO: TO: 1.

  • 1. Ind

ndus ustr try d y developed 2.

  • 2. Ind

ndus ustr try fund y funded CTO TO charac acteristic stics: Fee ee for se servi vice MD MD rev review ew Approval vals is issue ued in te ten bus busine iness day ays Iden dentifier: 6-dig igit it COM OMIRB # (exam ample: 12 12-11 1111 11)

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SLIDE 4

Req Requir ired Ap Approv

  • val

als s

CTO TO Pri rice Li e List & Nurs rsing Se Servi vices A s Approval val (fee f ee for s r serv ervice) Required d red docu cumen ents:  Pr Prot

  • tocol

 Attachmen ent W2 f for C r CTO TO  CTO/ TO/HRRC B Budge dget CTO Si Site A Approval val (MD rev review) w) Required d red docu cumen ents:  Pr Prot

  • tocol

 Attachmen ent W2 f for C r CTO TO  DS DSMB MB  Investiga gator Brochu chure re

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SLIDE 5

The Subm bmission ission P Process ss

St Step 1: 1: CTO TO has as a a par aralle allel r l revie iew p process. Th The f foll llowin ing d g documents mus ust be be subm ubmit itted to o

  • bt

btain in P Pric ice L Lis ist an and Sit Site Approval: al:  Protoc

  • col
  • l

 CTO O Attach chmen ent W2 W2  CTO/ O/HRRC B Budget et  Investig igat ator B Brochure ( (if if ap applic licab able le)  DSMB DSMB ( (if if ap applic licab able le) Yo You w will ill receiv ive t two ap approvals ls f from C CTO TO via ia email ail

  • CTO S

O Site A e Approval Let etter er

  • CTO

TO Pric ice L Lis ist an and Nur ursin ing Se Servic ices A Approval al

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SLIDE 6

CTO A Attach achme ment W2

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SLIDE 7

Data ta S Safety ty M Monitor itoring Boa

  • ard

DS DSMB MB

An independent DSMB is required for all Phase III multicenter studies that have more than minimal risk to the participant. This is necessary to ensure that we are in compliance with NIH policy.

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SLIDE 8

CT CTO / O / HRR HRRC Budget

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SLIDE 9

The Subm bmission ission P Process ss

Step 2 ep 2: Fill o

  • ut CTO

TO orde rder t r tem empl plates:  All i in On One e Ou Outpa patient Order Order Tem Templ plate  All i in On One e Inpa patient Order Tem Order Templ plate Ema mail il th these to to S Sus usan S n Switz itz A protocol i implementat ation m meeting will b be sc scheduled two wo week weeks f fro rom the da he date o e of rec receipt of the o he orde rders

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SLIDE 10

The Subm bmission ission P Process ss

St Step 3: 3: Attend P Protocol I Impleme mentation ( (PI) I) M Meeting All ll pertin inent s staf aff m mus ust at attend in includ ludin ing L Lab, ab, E Echo, Nut utrit ition, NP, O OP clinic, I , IP clinic, s , study c y coor

  • rdinators

rs; I ; Investigator

  • r

will ill at attend if if needed. Th The nur urse liais liaison w will ill br brin ing t the comple leted o

  • rders t

to t the meetin ing an and go go o

  • ver t

the flo low s sheets f for f fin inaliz alization. Please b be pr prepa pared to d to pa pay the the CT CTO adm dministrative ve f fee at t the the meet eeting ng.

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SLIDE 11

The Subm bmission ission P Process ss

Step 4 ep 4: Foll llow yo your ur no norma mal p l process fo for IRB submis ubmission a n and nd ap approval val CO COMIRB MIRB o

  • r WIRB

WIRB Step 5 ep 5: Submit to ubmit to H HRRC

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SLIDE 12

The Subm bmission ission P Process ss

Step 6 ep 6: Se Send al all final al ap approval val d documents t to Su Susan san Sw Switz  HRRC B Bus usine iness P Pla lan n with ith G Grant nt Numbe umber  Stamped A d Appro proved ed Consen ent  Req equest f for r App pplication R Rev eview ew  Cert ertificate o

  • f App

pproval / IRB  HIPAA AA A Approval val  HIPAA AA Authorizat zation t to Release ase D Dat ata  CV V for P r PI

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SLIDE 13

Othe her appr pprovals you you may ne need

 HRRC Hos

  • spi

pital l Research ch Revie iew Com

  • mmit

ittee  COMIRB Color

  • lorado

do Mult ultipl iple Instit itut utional l Revie iew Boa

  • ard

 WIR IRB Wes este tern I Insti titu tuti tional R Rev eview Bo Boar ard  Radiol diolog

  • gy

 Lab b (Cor

  • re – CTO) (Clin

linical l – UCH) )  Pha harmacy  Endos dosco copy

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SLIDE 14

CCTS TSI Colorad ado C Clinical al & Tran ansl slat ational al Sc Sciences I Inst stitute http ttp://c //ccts tsi/P /Pages/i /ind ndex.aspx

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