NOTES FOR THE MEETING

Notes for the Meeting



Notes for the Meeting

Questions for the Meeting

Need clarification/guidance on a list of essential documents that must be in eTMF/ISF. CRAs need to know what needs to be reviewed on site or remotely (Elhard, 2004).

No email follow-up email to site within 5 business days. Simply send a signed PDF letter within 5 business days (Elhard, 2004).

Re-word time frame for first IMV post 1st subject randomized (within 3 weeks).

TR guidelines - Ask CRA's to add wording around sites risk level in TR.

Design tool to help CRAs schedule visits based on low, medium, high risk visits.

Look at a more random approach for 20% SDV.

Will follow-up letter disclose reduced SDV?

Look at DB/eCRF - how to capture remote versus onsite SDV.

Revise wording - drug accountability/drug return during interim visits; do complete check on final subject on log just in case it happens to be the last subject at the site.

If a subject does not return their clinical supplies “replacement” kit for any reason, how do we re-issue a new “replacement” kit?

Schulman - do we need to submit non drug related SAEs to them? Get confirmation and share with the team.

Whether to provide mailing boxes and shipping labels for subjects that SF but do not want to return to the site. Otherwise we will have difficulty getting back the clinical drug supplies and the diary (MacMillan, 2007).

Do we provide a tote for subjects to bring study clinical supplies to and from the visit? (MacMillan, 2007).

Will we provide posters, pt recruitment materials to the sites? Will we supply patient kits?

Is there a specific time limit or window that subjects must have completed a second/repeat assessment? PI must obtain results and use their judgment to make their decision, whatever is in the best interest of the subject.

Answers for the Meeting

Subjects with pacemakers cannot participate in PT003007 sub study.

It is not stated in the protocol a maximum time window that the 14 day post study drug follow-up needs to be conducted/captured. As per Earl, there is a ± window of 7 days but as this is not documented it may be difficult to enforce sites to conduct it exactly at this time.

Three criteria used for subject stratification is reversibility, severity of COPD, and 12 hour spirometry results.

Illiterate subjects cannot be included in the trial because of the need to complete ePROs and note compliance for use of study drug.

Do patients develop antibodies to components of our study medications? It may be assumed that if this was the case there would be a lack of efficacy. We are not aware of a facility that tests for antibodies to Glycop.

Perhaps the Clinical Team needs to set rules for the time period allowed for re-assessment.

IM Emphasize that Repeat Labs MUST be done at the central lab. Use of a Local lab is unacceptable.

3 moderate exacerbations that occur in a subject in a 6 month period or 1 severe exacerbation involving Hospitalization = grounds for Early ...