Reporting period: Monthly Status Report Insert logo here

J A N 1 9 Study code: enter here

M M M Y Y

1.0 GENERAL INFORMATION

Blue text in italics serves as a guide and an example. Please delete it before
finalizing the report.

PM: Title, Name, Surname Date: DD MMM YYYY

Sponsor:

Please document below the status on the last working day of the current month:
PATIENTS TOTAL CURRENT COUNTRIES/SITES TOTAL CURRENT
MONTH ** MONTH**
Screened ENTER ENTER No of countries ENTER ENTER
patients * NUMBER NUMBER selected NUMBER NUMBER
HERE HERE HERE HERE

Screening ENTER ENTER No of countries ENTER ENTER

failures NUMBER NUMBER opened NUMBER NUMBER
HERE HERE HERE HERE

Randomized ENTER ENTER No of sites ENTER ENTER

patients NUMBER NUMBER selected NUMBER NUMBER
HERE HERE HERE HERE

Treated ENTER ENTER No of sites ENTER ENTER

patients NUMBER NUMBER opened NUMBER NUMBER
at least one dose HERE HERE HERE HERE
received
Completed ENTER ENTER No of countries ENTER ENTER
NUMBER NUMBER closed NUMBER NUMBER
HERE HERE HERE HERE

Discontinue ENTER ENTER No of sites ENTER ENTER

d NUMBER NUMBER closed NUMBER NUMBER
HERE HERE HERE HERE

*signed the ICF/assent ** write only the net change from the last month

Top recruiters Site No No. of randomized

patients*
PI Title, Name Surname e.g. 032 25

Are patient recruitment projections being met? YES NO

Please comment. Confirm whether any corrective and preventive actions have
been implemented in case recruitment is behind the schedule.

Status Report Template ADAPT BEFORE USE Created By: Danilo Uvalin, PMP
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 Reporting period: Monthly Status Report Insert logo here

J A N 1 9 Study code: enter here

M M M Y Y

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 Reporting period: Monthly Status Report Insert logo here

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M M M Y Y
Please update the recruitment graph. Enter the cumulative planned and actual numbers of RANDOMIZED patients.

Recruitment Graph

410
393
374
352
334
310
Randomized Patients

286
268

235
221
210
184 189
176
155
145
121
103 96
88 89
73 66
54
45
36
22 18 25
10 12
2
Jan 18 Feb 18 Mar 18 Apr 18 May 18 Jun 18 Jul 18 Aug 18 Sep 18 Oct 18 Nov 18 Dec 18 Jan 19 Feb 19 Mar 19 Apr 19 May 19 Jun 19 Jul 19

Time
Planned Actual

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 Reporting period: Monthly Status Report Insert logo here

J A N 1 8 Study code: enter here

M M M Y Y

2.0 PROJECT STATUS

For the following project constraints, select the appropriate status.

Good or Bad or Additional details

Legend
acceptable unacceptable* needed **

1. Timelines On Schedule Behind Schedule Ahead of

Schedule

2. Budget On Budget Above Budget Below Budget

3. Scope Unchanged Increase in Scope Decrease in

Scope

4. Quality No major issues Major Issues Some minor

Issues

5. Resources Adequate Inadequate

Low Medium High

6. Project Risk

*Please always comment below in the appropriate section.

** Please provide further details in the appropriate section.

The project risk assessment can only be fully understood after the Risk Log analysis.

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M M M Y Y

2.0 PROJECT STATUS (continued)

1. TIMELINES:

Milestone: Schedule Planned Date* Actual Date**

Baseline date
First Site initiation (SIV): 14-Dec-2017 22-Dec-2017 09-Jan-2018

First Patient In (FPI): 22-Dec-2017 08-Jan-2018 27-Jan-2018

25% Recruitment: 20-Jun-2018 13-Jul-2018 14-Sep-2018

50% Recruitment: 21-Sep-2018 12-Oct-2018 04-Jan-2019

75% Recruitment: 10-Jan-2019 15-Feb-2019

Last Patient Out (LPO): 03-Jun-2019 12-Jul-2019

100% Recruitment
Database Lock: 12-Jul-2019 15-Aug-2019

Top line results: 22-Jul-2019 30-Aug-2019

Clinical Study Report 23-Sep-2019 24-Oct-2019

final:
* The current planned date according to the schedule. If milestone already achieved, leave the planned date in.
** The date when the milestone was achieved, ideally the same as the planned date. Always document this date.

Please attach the current approved schedule to this report (e.g. Microsoft Project
Schedule).

Is the project on schedule?

YES NO
If behind schedule, please document the preventive and corrective actions taken to
bring the project back to schedule (e.g. fast tracking, crashing).

Please comment.

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M M M Y Y

2. BUDGET

Have there been any changes to the budget during

YES NO
the reporting period?
Please comment only if there was an official budget change request submitted by a
vendor, or the need for the budget update has been identified within the company.

3. SCOPE

Have there been any changes to the scope during the

YES NO
reporting period?
Increase or decrease in the number of selected countries and sites, new analysis
and tests, new vendors etc.

4. QUALITY

Have there been any audits or regulatory inspections

during the reporting period? Mention any quality YES NO
issues.
Please specify and provide a short summary, highlight any issues and CAPAs.

5. RESOURCES

Have there been any issues with resources during the

YES NO
reporting period?
Please mention any issues with the workload and staffing.

6. RISK

Have there been any specific project risks (threats)

that required immediate actions during the reporting YES NO
period?
Please specify and don’t forget to add these risks to the Risk Log.

Please attach the current Risk Log and Issue Log to this report.

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M M M Y Y

3.0 SUMMARY

KEY ACCOMPLISHMENTS

Provide a short summary about the major accomplishments for the reporting
period.

GOALS FOR THE NEXT MONTH

Summarize the most important goals for the upcoming month.

ATTACHMENTS:

Insert the document here using the Insert -> Object

ISSUE LOG function in MS Word or alternatively distribute as an
attachment to the email together with this report.
RISK LOG Same as above

SCHEDULE Same as above

OTHER: Same as above

(e.g., list of sites)

Distribute this report to:

 Title, Name – Role

 Title, Name – Role
 Title, Name – Role
 Title, Name – Role
 Title, Name – Role
 Title, Name – Role
 Title, Name – Role
 Title, Name – Role

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