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

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 Leprino Building : 12 th th Floor A Inp npatie tient nt C CTO : r Anschu chutz Inpat atient P Pavi avilion / / 12E

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

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)

Req Requir ired Ap Approv oval als s  CTO  CTO Si TO Pri rice Li e List & Nurs rsing Site A Approval val Se Servi vices A s Approval val (MD rev review) w) (fee f ee for s r serv ervice) Required d red docu cumen ents: Required d red docu cumen ents:  Pr Prot otocol  Pr Prot otocol  Attachmen ent W2 f for C r CTO TO  Attachmen ent W2 f for C r CTO TO  DS DSMB MB  CTO/ TO/HRRC B Budge dget  Investiga gator Brochu chure re

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

CTO A Attach achme ment W2

Data ta S Safety ty M Monitor itoring Boa oard 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.

CT CTO / O / HRR HRRC Budget

The Subm bmission ission P Process ss Step 2 ep 2: Fill o out 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

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 ordinators rs; I ; Investigator or will ill at attend if if needed. Th The nur urse liais liaison w will ill br brin ing t the comple leted o orders t to t the meetin ing an and go go o over 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.

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

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 of 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

Othe her appr pprovals you you may ne need  HRRC Hos ospi pital l Research ch Revie iew Com ommit ittee  COMIRB Color olorado do Mult ultipl iple Instit itut utional l Revie iew Boa oard  WIR IRB Wes este tern I Insti titu tuti tional R Rev eview Bo Boar ard  Radiol diolog ogy  Lab b (Cor ore – CTO) (Clin linical l – UCH) )  Pha harmacy  Endos dosco copy

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