CR $020$ Assignment description

$1.$ Open a free $30$ day trial account $($no cc required$)$ at www$.$gantter.com.

$2.$ Please create a Gantt chart for the following hypothetical clinical trial using the flowchart and the additional information provided below.

$3.$ Save your Gantt chart as pdf and upload into Brightspace prior to the last class$/$session of the course.

Additional information:

$1.$ The phases of the study $($start$-$up$,$ conduct, closeout$)$ are main task, the task within these main tasks are subtasks $($use indent$)$

$2.$ Assign the task as noted by each subtask

a$.$ MW$-$ medical writer

b$.$ CRA$-$ clinical research associate

c$.$ PI$-$ principal investigator

d$.$ DM$-$ data management

e$.$ CRC$-$ clinical research coordinator

f$.$ CMO$-$ contract manufacturing organization

g$.$ ST$-$ Statistician

h$.$ AD$-$ Administrator

i$.$ DS$-$drug safety

$3.$ Indicate dependencies $($i$.$e$.$: protocol has to be written for site feasibility$)$

$4.$ Add time requirement $($duration$)$ as noted

$5.$ Assign the following risks:

a$.$ Budgeting: sites are asking for higher than budgeted site$/$per patient payments

b$.$ IRB approval takes longer than anticipated

c$.$ IP does not arrive on time for FPI at sites

d$.$ Site audit finds critical errors

e$.$ Data management: sites are slow to respond to data queries, potentially delaying database lock

Pls note that this is an example for the purposes of demonstrating Gantt chart creation skills and does not aim to show the complexity of a real clinical trial.