Hur on We binar Se r ie s: Data Migr ation Date s, Re vise d - PowerPoint PPT Presentation

Hur on We binar Se r ie s: Data Migr ation Date s, Re vise d Doc ume nts for Ne w Submissions, and Othe r Ne ws! Se pte mb e r 12, 2019

Da ta Mig ra tio n Da te s T opic s to I mpo rta nc e o f Ne w T e mpla te s Cove r Ne w Pro to c o l T e mpla te s Ne w Che c klists Othe r Ne ws Que stio ns

Impor tant Notic e All the fo llo wing da te s a re sub je c t to c ha ng e de pe nding o n te c hnic a l issue s we ma y find a lo ng the wa y!

Antic ipa te d Sc he dule during Da ta Mig ra tion  Co ntinuing re vie ws fo r studie s e xpir ing Januar y/ thr e e fir st we e ks in F e br uar y  Sub mit re ne wa l a pplic a tio n in Nove mbe r  Stra te g ic slo wdo wn o f sub missio ns (ne w a nd a me ndme nts): Ja nua ry 7 thro ug h g o - live Ja nua ry 31  Ne w Studie s: L imite d to inte rve ntio na l studie s with the se c rite ria :  Co mpe titive e nro llme nt o r c o ntra c tua l o b lig a tio n fo r q uic k sta rt-up (e .g . NCI g ra nt)  I RB is limiting fa c to r in sta rt-up (i.e . do no t sub mit if c o ntra c t, e tc . will no t b e re a dy)  Othe rs: ho ld until ne w syste m g o -live (c o nsult I RB le a de rship if spe c ia l c o nc e rns)  Any studie s sub mitte d: ne e d to wra p up within 90 da ys o f g o -live , e lse must re sub mit in ne w syste m

Antic ipa te d Sc he dule during Da ta Mig ra tion  Stra te g ic slo wdo wn o f sub missio ns (ne w a nd a me ndme nts): Ja nua ry 7 thro ug h g o - live Ja nua ry 31-Co ntinua tio n…  Ame ndme nts: o nly if upda ting pro to c o l, I B, c o nse nts, o r o the r study do c ume nt whe n imme dia te c ha ng e is re q uire d b y Spo nso r o r a ffe c ts sa fe ty/ we lfa re o f sub je c ts. Ame ndme nts fo r no n-urg e nt c ha ng e s sho uld b e he ld until g o -live  Re po rta b le e ve nts: Sub mit a s usua l in the c urre nt e I RB syste m  Co ntinuing Re vie ws: ho ld until ne w syste m g o -live  WI RB a nd o the r E xte rna l I RB-Re vie we d Studie s: we will ha ve a no the r wo rkflo w a va ila b le o utside e I RB

Antic ipa te d Sc he dule during Da ta Mig ra tion  Ge ne ra l Re c o mme nda tio ns  Ma ke sure to sa ve yo ur re c ruitme nt ma te ria ls ! Studie s will b e mig ra te d a nd sna psho ts o f the info rma tio n will b e ke pt b ut re c ruitme nt ma te ria ls will not b e mig ra te d to the re c ruitme nt se c tio n in the ne w Sma rtfo rm. T ho se will ne e d to b e a dde d b a c k in a fte r g o -live  Sa ve c o pie s o f yo ur c onse nt forms b e fo re the g o -live . T he syste m will ha ve a c o py b ut we wa nt to ma ke sure yo u ha ve wha t yo u ne e d in c a se the re a re a ny te c hnic a l issue s during tha t pe rio d.  Use o ur ne w pro to c o l a nd c o nse nt fo rm te mpla te s a nd sma rt-fo rm te mpla te to work on your submission during the slowdown

CR sub missio n fo r stud ie s e xpiring in Ja nua ry/ thre e Sta rt o f Ne w Sub missio n/ AM first we e ks o f F e b rua ry Slo wd o wn 24 De c . 2019 – 1 Jan. 2020 31 Jan. 2020 Nov 2019 7 Jan, 2020 E mo ry Winte r Re c e ss Ne w Syste m Go live

Se ve ra l q ue stio ns in the c urre nt sub missio n fo rms will no t a ppe a r in the ne w e I RB Impor tanc e T he pro to c o ls will ne e d to c o ve r tho se a re a s tha t a re no lo ng e r in the sub missio n of Ne w T e mplate s Critic a l: yo u must use o ur te mpla te s! F o r e xte rna l pro to c o ls: yo u must use o ur a dde ndum

 We ha ve sa ve d the se te mpla te s a t http:/ / www.irb .e mo ry.e du/ e irb _pro je c t_huro n_sa a s/ Ne w_T e mpla te s.html  Our re vise d te mpla te s a re a s fo llo ws: Ne w Pr otoc ol  Bio me dic a l Pro to c o l T e mplate s  So c io -b e ha vio ra l Pro to c o l  Site Supple me nt to Spo nso r Pro to c o l  Re tro spe c tive Cha rt Re vie w Pro to c o l  Se c o nda ry Ana lysis Pro to c o l

Ne w Che c klists T e rmino lo g y upda te ! “Che c klists” = ne e d to b e fille d o ut a s pa rt o f Use d to c a pture So me c he c klists will b e the I RB sub missio n (so me impo rta nt re g ula to ry fa milia r, so me will b e b y study te a m, so me b y info rma tio n ne w o r upda te d I RB sta ff o r re vie we rs) “Wo rkshe e ts” = fo r I RB sta ff re fe re nc e prima rily

T he se a re the c urre nt c he c klists o n o ur we b site tha t will not b e upda te d:  Mo b ile Me d ic a l a pps wo rkshe e t (will b e c a lle d “c he c klist” mo ving fo rwa rd )  De pa rtme nt o f De fe nse Stud y Che c klist  ICH-GCP E 6 Che c klist  Mo b ile Me d ic a l a pps wo rkshe e t (will b e c a lle d “c he c klist” mo ving fo rwa rd ) Ne w  RE MS Che c klist Che c klists  Die ta ry Supple me nts a nd / o r Me d ic a l F o o d s Wo rkshe e t (will b e c a lle d “c he c klist” mo ving fo rwa rd)  Huma nita ria n Use De vic e (HUD) Che c klist  Inve stig a to r Justific a tio n fo r IDE E xe mptio n  Inve stig a to r Justific a tio n fo r IND E xe mptio n  Inve stig a to r Che c klist fo r the Use o f Sc he d ule I Co ntro lle d Sub sta nc e s  F E RPA_Guid a nc e _a nd _Che c klist

 Upda te d Che c klists fo r I RB sta ff use – a va ila b le fo r study te a m re fe re nc e :  HRP-415 - CHE CK L I ST – Priso ne rs Ne w  HRP-416 - CHE CK L I ST – Childre n Che c klists  HRP-417 - CHE CK L I ST - Co g nitive ly I mpa ire d Adults  Sub pa rt B wo rkshe e t

Othe r syste m upg ra de upda te s Study-Sta ff Cha ng e Re q ue sts:  Curre ntly: using o nline to o l, no ne e d fo r e I RB a me ndme nt  Ne w e I RB: a ll sta ff c ha ng e s will re q uire a n a me ndme nt  Go o d ne ws: o nly o ne fo rm, so e a sy to c o mple te  I t will no t re q uire PI sig n o ff if he / she ide ntifie s a pro xy fo r sub missio n  With this type o f a me ndme nt, a no the r a me ndme nt c a n b e o pe n a t the sa me time !

Que stions?