Job Aid Title Relevant Users Covered Topics ! Note: Please refer to Section 4 below for Closure Submission instructions.

Transcription

1 Jb Aid Title Relevant Users Cvered Tpics Hw t Submit a Cntinuing Review, Cntinuing Review/Mdificatin, r Clsure Principal Investigatr (PI), Additinal Cntact, Study Staff Hw t create and submit a Cntinuing Review, Cntinuing Review/Mdificatin, r Clsure! Nte: Yu can nly submit ne Cntinuing Review, r Cntinuing Review/Mdificatin, r Mdificatin submissin at a time. If yu have submitted a plain Cntinuing Review that has nt yet been apprved and yu need t submit a Mdificatin t the study, please cntact the IRB ffice fr assistance (x6-4261). If yu have submitted a Cntinuing Review/Mdificatin that has nt yet been apprved and yu n lnger want the IRB t review the Mdificatin with the Cntinuing Review, please cntact the IRB ffice fr assistance (x6-4261). Please refer t Sectin 4 belw fr Clsure Submissin instructins. 1. Create a Cntinuing Review r Cntinuing Review/Mdificatin Once in the Parent study (i.e., the study s initial submissin in eirb), select the New CR/Mdificatin buttn as shwn belw. Select either Cntinuing Review r Cntinuing Review and Mdificatin in (1). Then review the Current Prtcl Status in and select any f the fur statements that are true r nt applicable. Click Cntinue. 1

2 The submissin nickname shuld describe the particular fllw-n submissin. (1) 2. Submit a Cntinuing Review nly Cmplete the Cntinuing Review Status Sectin as required. Click Cntinue again t mve t the Cntinuing Review Infrmatin Sectin and cmplete as required. Uplad a brief summary f the prgress f the research in (1).! Nte: When yu click yes t any f the questins in shwn belw, yu are required t attach a summary explanatin fr each item in (3). This is in additin t the brief summary f the prgress f the research in (1). Yu may wish t create ne dcument cntaining bth the brief prgress summary and the explanatins fr each questin answered as yes. If yu cmbine int ne dcument, and yu have n ther attachments t add t (3), yu may uplad the dcument in bth (1) and (3). If UMass Wrcester is the primary awardee f federal funds (e.g., NIH), be sure t uplad a cpy f the mst recent federal prgress reprt in (3). Or, explain why there is n prgress reprt (e.g., in a n cst extensin). 2

3 (1) (3) 3. Submit a Cntinuing Review/Mdificatin T submit bth a Cntinuing Review and Mdificatin tgether, yu will cmplete all fields described abve. Yu will then be prmpted t cmplete a mdificatin submissin (shwn belw). Refer t the Hw t Submit a Mdificatin Jb Aid fr a detailed descriptin f the required elements f a mdificatin submissin, as well as step-by-step submissin instructins. 4. Creating a Clsure submissin!nte: Clsure submissins are submitted as the study s final Cntinuing Review. Create a Cntinuing Review Submissin as instructed abve in Sectin 1, Create a Cntinuing Review r Cntinuing Review/Mdificatin. Select Cntinuing Review in (1). 3

4 In rder fr the study t meet the criteria fr clsure, all 4 items under Current Prtcl Status must be true r nt applicable. (1) Cmplete the submissin as yu wuld a plain Cntinuing Review (detailed abve in Sectin 2, Submit a Cntinuing Review nly).!nte: In the summary f the prgress f the research: If applicable, cnfirm that all subjects have cmpleted all research related interventins and interactins. If applicable, cnfirm that any remaining data being analyzed has been cmpletely annymized and des nt include subject Prtected Health Infrmatin (PHI) r Persnally Identifiable Infrmatin (PII). If the research is spnsred by an external funding surce (e.g., Industry, Cperative Grup, etc.), uplad crrespndence frm the Spnsr cnfirming that all clsure activities have been cmpleted (as applicable) and that the study may be clsed in (3) Attachments (shwn abve in Sectin 2, Submit a Cntinuing Review nly). 5. Submitting the Cntinuing Review, Cntinuing Review/Mdificatin, r Clsure Submissin Fr Study Staff: After clicking Finish r Exit in the submissin, select Ready fr PI Review under My Current Actins in the submissin wrkspace. The PI is the nly member f the study team that may submit the CR, CR/Md, r Clsure t the IRB ffice. 4

5 Fr the PI: After clicking Finish r Exit in the submissin, select Submit under My Current Actins in the submissin wrkspace. Yu will knw that yu have submitted successfully when the submissin s state in the upper left-hand f the screen has changed frm Pre-submissin t Pre-Review. 5