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I apologize! The other day when I wrote about getting approvals at Research In Motion (RIM®) to attend BlackBerry World™ and introducing Scott Totzke's personal invitation to Government Day at BlackBerry World, I suggested that you, my IT leader readers, somehow have it easy. Perhaps I even insinuated that getting approval to attend BlackBerry World was a cake walk, and that only I had to suffer through justification and business case presentations. But clearly this is not the case! As many folks have pointed out, your budgets are tight, time is never on your side, and you have to justify conference attendance just like I do.
Having attended BlackBerry World since the inaugural event (back in the days when it was WES!), I often take for granted that customers (and their bosses) inherently understand the value of the conference. After all, once you've attended, you just get it. In fact, based on our BlackBerry World 2011 Survey:
- 96% of attendees stated that "attending BlackBerry World was important to their organization"
- 99% of attendees "would recommend BlackBerry World to a colleague", and
- 98% of attendees "plan to attend BlackBerry World again" (hopefully taking advantage of the alumni discount!)
But if you've never attended BlackBerry World, you wouldn't know the experience for yourself. So, in addition to my apology, I've pulled together some reasons for attending BlackBerry World that you should consider.
Have a look at this presentation for the details: "Roger's Top 5 BlackBerry World 2012 Attendance Justification Conversations To Have With Your Boss At The Water Cooler".
Also, the BlackBerry World Conference catalogue covers a broad range of topics — you just might find exactly what you're looking for. In fact, 84% of the attendees surveyed at BlackBerry World 2011 reported that "the breakout session catalog covered the topics they wanted to hear about."
But beyond my "BlackBerry World 2012 Attendance Justification Conversations" – and in addition to all the work that goes into scheduling, preparing, promoting, learning from, and implementing various sessions – deep down, I think the single most valuable part of BlackBerry World is the people. I can't put a price on this, or explain how it happens, but BlackBerry World simply brings so many of the right people together and creates the right environment that 'magic' is bound to happen. I've personally experienced it every year I've attended. You just might sit down to lunch and within minutes realize you're seated with the one developer that has the exact application you're after, an industry analyst who consulted on a similar business issue in Europe last year, a manufacturing customer who faced similar implementation challenges, and a system integrator that's based near your office, but you've never run into before! Getting this brain trust together could take months of voicemail-tag and email trails. This fortuitous meeting of the minds can be invaluable. In fact, 88% of last year's surveyed attendees claimed "BlackBerry World helped them meet colleagues (with whom) they would collaborate with in the future."
So whether you base your attendance on the content or the networking, there's something for everyone at BlackBerry World. So consider registering for BlackBerry World today…and if my "BlackBerry World 2012 Justification Conversations" do the trick, your boss might even come along, and maybe your team might then be able to take advantage of the group discount! Of course, you'll have to be on your best behavior if the boss is beside you – but having them see firsthand the potential positive impact mobile technology can have on your company's business could be worth the effort!
How do you justify conference attendance? Do you have a budget for the year? Per Person? Per topic? What do you say to convince your boss to approve BlackBerry World attendance? I'm sure your peers could benefit from your experience!


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- Home
- Drugs of Abuse
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- Publications
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- About NIDA
Guidelines for Developing a Data and Safety Monitoring Plan
- Funding Opportunities
- Clinical Research
- Regulations, Policies, and Guidance
- Guidelines for Developing a Data and Safety Monitoring Plan
- Draft Guidelines for Establishing and Operating a Data and Safety Monitoring Board
- NACDA Guidelines for Administration of Drugs to Human Subjects
- NACDA Guidelines for Substance Abuse Research Involving Children and Adolescents
- Bioethics
- More Clinical Trials Information
- Post-Award Concerns
- General Information
- Grant & Contract Application Process
- Funding Priorities
- Research Training
The National Institute on Drug Abuse (NIDA), to assist grantees conducting or planning to conduct clinical trials, has developed these guidelines for data and safety monitoring (DSM) plans, in accordance with NIH requirements. The purpose of the DSM plan is to ensure the safety of participants in clinical trials and the validity of trial results.
Grant applicants must submit a general description of the DSM plan as part of the research grant application. The Scientific Review Group will review the DSM plan and any comments or concerns will be included in the summary statement. A detailed DSM plan must be submitted to and approved by NIDA before the trial begins. The responsibility for compliance with the DSM plan rests with the grant recipient.
These guidelines do not take the place of Institutional Review Board (IRB) guidelines, Food and Drug Administration (FDA) requirements, or special NIH guidelines, e.g., NIH Guidelines for Research Involving Recombinant DNA Molecules. Specifically, Phase I and II gene transfer trials must comply with additional requirements imposed by NIH Guidelines, e.g., reporting of adverse events to the Office of Biotechnology Activities.
In June of 1998, NIH issued a policy stating that "each Institute or Center (IC) in NIH should have a system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all NIH-supported or conducted clinical trials." According to this policy, data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III); etc. It includes all types of intervention studies, whether medication or non-medication (e.g., behavioral, prevention, diagnostic) trials. Monitoring should be commensurate with the study risks. This policy provides each IC with the flexibility to implement the requirement for data and safety monitoring as appropriate for its clinical research activities. (http://grants.nih.gov/grants/guide/notice-files/not98-084.html)
Further guidance to this policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html), released in June of 2000, stated that beginning with the October 2000 receipt date, investigators must submit a monitoring plan for Phase I and Phase II clinical trials to the IC before the trial begins. Also, a general description of data and safety monitoring plans must be included as part of the competing grant application.
Trials that require a DSM Plan/Board
Figure 1 shows a decision tree to determine the need of a DSM plan and/or a DSM Board. According to the NIH DSM policies, DSM plans are required for all clinical trials of all phases for which grant support is sought. For the purpose of these guidelines, a clinical trial is a prospective study to test the effect of a biomedical or behavioral intervention in human subjects. It includes medications, herbal/nutritional supplements, physical interventions, behavioral interventions, prevention trials, and/or diagnostic tools that affect the outcome of the study participants.
The requirement of a DSM plan covers career and training awards in which the trainee has direct responsibility for conducting a clinical trial or in which award funds directly support a clinical trial.
Grants that include multiple clinical trials must submit a DSM plan to NIDA prior to initiation of each new trial. Initial funding of a grant and continuation of funding will be contingent on the Institute's acceptance of the DSM plans.
In addition to the DSM plan, a Data and Safety Monitoring Board (DSMB) is generally required for Phase III clinical trials. For earlier medication trials (Phase I or II) and some behavioral clinical trials, a DSMB may be appropriate if the study has multiple clinical sites, is blinded, tests a high-risk intervention, or is conducted in vulnerable populations. Generally, Phase III trials involve larger numbers of subjects, but size is not a specific criterion for this designation.
The purpose of the DSMB is to monitor the safety of the interventions and the validity and integrity of the data from clinical trials that require a DSMB. The decision to establish a DSMB is commensurate with the level of risk and/or the number of treatment sites participating in the study. A DSMB may be required by the grantee's institution, but the ultimate decision rests with the sponsoring Institute. In conducting its reviews and making recommendations, the DSMB works to assure that the safety of study subjects is protected while the scientific goals of the study are being met. In monitoring the data and safety of the trial, The DSMB may recommend continuation of the trial, modifications to the trial, or termination of the trial in the event of overwhelmingly significant efficacy difference between groups or unacceptable adverse events.
Adverse events are defined as any untoward medical occurrence that may present itself during treatment or administration of an intervention, and which may or may not have a causal relationship with the treatment. Serious adverse events are defined as any medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; creates persistent or significant disability/incapacity, or a congenital anomaly/birth defects. Adverse events and serious adverse events may occur in medication and non-medication trials. In non-medication trials, for example, AEs may include suicidal ideation/attempts, drug or alcohol overdose/withdrawal, etc. Guidance about definitions and reporting of AEs and SAEs can be obtained at:
- http://grants2.nih.gov/grants/guide/notice-files/not99-107.html
- http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ContactCDER/default.htm
- http://www.fda.gov/Safety/MedWatch/default.htm
Figure 1. DSM Plan/Board Decision Tree
Elements of a DSM Plan
The overall elements of the DSM plan may vary depending on the potential risks, complexity, and nature of the trial. They also depend on whether it is an initial or a detailed DSM plan.
Initial DSM plan
Research grant applications that involve clinical trials must include a general description of the DSM plan. The PHS 398 application instruction indicates where to place this description and what to include. The initial DSM plan should include a brief description of data management methods, collection and reporting of Adverse Events (AE) and Serious Adverse Events (SAE), medical safety measures, communication plan with IRB/FDA/NIDA, interim analysis plans, and content and frequency of DSM reports to NIDA. The entity responsible for monitoring should be specified. The Scientific Review Group reviews the initial DSM plan and may provide comments or concerns, which are included in the summary statement. Appendix B, C, and D have samples of initial DSM plans for pharmacotherapy, behavioral, and prevention trials, respectively.
Detailed DSM plan
A detailed DSM plan must be submitted to and approved by NIDA before starting a new trial. Appendix A has a checklist of the basic elements of a detailed DSM plan. The responsibility for compliance with the DSM plan rests with the grant recipient. Notice of Grant Awards (NGA) will include terms to put into effect NIH DSM policies.
The detailed DSM plan should include:
Summary of the protocol
- Brief description of the protocol (Study design)
- Primary and secondary outcome measures
- Inclusion/exclusion criteria
- Power calculation and sample size
Trial Management
- List of participating enrolling clinics or data collection centers
- Projected timetable
- Target population distribution (e.g, women, minorities, etc)
Data Management and Analysis
- Data acquisition and transmission
- Data entry methods
- Data analysis plan
Quality Assurance
- Procedures in place to ensure the validity and integrity of the data
- Procedures to guarantee the accuracy and completeness of the data, during data collection, entry, transmission, and analysis.
Regulatory Issues
Reporting of SAEs
- Medication trials: to the IRB, NIDA, and, as applicable to the FDA.
- Non-medication trials: to the IRB and NIDA.
- Reporting of IRB actions to NIDA
- Report of changes or amendments to the protocol
- Trial stopping rules
- Disclosure of any conflict of interest in the DSM
Trial Safety
- Potential risks and benefits for participants
- Collection and reporting of AEs and SAEs
- Management of SAEs or other study risks
Trial Efficacy
- Plans for Interim Analysis of efficacy data
DSM Plan Administration
Responsibility for data and safety monitoring
- Persons responsible for monitoring the trial
Frequency of DSM
- How often are the data reviewed in the course of the trial?
Content of DSM report
- Brief description of the trial
- Baseline sociodemographic characteristics
- Retention and disposition of study participants
- Q.A. Issues
- Regulatory Issues
- AEs
- SAEs
- Efficacy
If applicable, DSM Board Plan
- Members and affiliation
- Frequency of meetings
- Conflict of interest
- Protection of confidentiality
- Monitoring activities (initial and ongoing study review)
- Communication plan to IRB, NIDA, and FDA (if applicable)
Review of DSM Plans by NIDA Staff
The Project Officer assigned to the grant will review the DSM plan prior to starting the trial. The review focuses on the quality of the process that the investigator is planning to have in place to ensure the safety of the participants and obtain reliable results. The Project Officer's review is based on the adequacy with which the plan covers the essential elements outlined above. According to NIH policy, the detailed monitoring plan must be included as part of the protocol and submitted to the local IRB and reviewed and approved by the funding Institute and Center (IC) before the trial begins. The responsibility for compliance with the DSM plan rests with the grant recipient. Appendix E shows the review process for DSM related actions.
For questions or comments please contact:
Ivan D. Montoya, M.D., M.P.H.
Medications Research Grants Branch
Division of Treatment Research and Development
6001 Executive Blvd.
Bethesda, MD 20892-9551
Phone: (301) 443-8639
Fax: (301) 443-2599
e-mail: firstname.lastname@example.com
Appendix E. – DSM Plan Review Process
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Mentoring: A Guide for Drug Abuse Researchers
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subset: commoncrawl


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Marriage repair
A couple months ago they were on life support. Kate Beckinsale had taken off for London without warning husband Len Wiseman, stayed there a month, found daughter Lily a new school, leaving Len supposedly baffled about what prompted her decision.
Her rep vehemently denied there was anything wrong between the two. But according to my sources they were indeed apart for several weeks and that Kate had also consulted a divorce lawyer and was prepared to move forward…
Some time mid April she returned to LA and after a series of long discussions apparently agreed to give it another go. Paps were quickly called, happy photos were taken, not unlike the happy photos taken this long weekend of the two in Malibu, out and about with Lily and also at that celebrity-heavy party yesterday.
What was the reason for their troubles? Rumour has it she's been extremely dissatisfied with her stalled career. She'd planned to be much further along at this point. Instead Kate Beckinsale is lost in the pack. Kate turns 36 this summer. Other actresses in the same age range:
Winslet, Blanchett, Weisz, Paltrow, Diaz, Cruz, Theron, Jolie, Connelly….
I mean, really. She's lucky if she makes Page 2, right?
Therefore the frustration. So they say she took it out on her marriage. And her wardrobe. Because that totally explains the overdressing, non?
Speaking of overdressing…
Did you see Elsa f-cking Pataky at the Inglourious Basterds premiere in Cannes last week?
NO IDEA what she was doing there. Or anywhere.
But that gown. The train on that gown going up the steps, we counted, Laura and I, we counted that it spanned FIVE STEPS.
Sit DOWN Elsa Pataky.
Tuesday, May 26, 2009 at 7:29 AM
posted 02:12 Labels: 2009, Kate Beckinsale, Len Wiseman, reveal


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If you are a Facebook user and are having trouble signing into your account, visit our Help Center.
See our new Facebook Login changelog to see a summary of recent changes.
Core use cases and features for Facebook Login.
Logging people in to your app.
Asking for permissions to access data.
Permissions enable you to request access to additional info about someone using your app.
If your app requests information beyond people's default profile fields and email, you need to submit your app for Login Review.
How to design a great user experience with Facebook Login.
Access tokens are random strings that give you temporary secure access to our APIs.
Common scenarios to test to ensure your Facebook Login implementation works reliably.
Follow these tips to ensure your integration provides the best experience possible.
Ensure your existing account system and your Facebook Login implementation work well together.
Enhance the account security of your Facebook Login integration.
For particularly sensitive app operations like making purchases or changing settings, you may want to ask people re-enter their Facebook username and password.
Learn how implementing Facebook Login in apps has improved login rates and enhanced customer experience. In particular, see the following case studies:
Saavn — 65% higher engagement, 3 times more shares, 15 times more visitors from Facebook.
Skyscanner — 100% increase in Facebook Login conversions.
For phone-number or email login that doesn't require that people have a Facebook account, see Account Kit.
Udacity training for Facebook Login and Account Kit.
GitHub example of an Android implementation of Facebook Login.


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The "alkaline" in alkaline water refers to its pH level. The pH level is a number that measures how acidic or alkaline a substance is on a scale of 0-14. For example, something with a pH of 1 would be very acidic, and something with a pH of 13 would be very alkaline.
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When it comes to health, water is kind of a big deal. In fact, no other substance is as important for our bodies. So if you're consistently drinking water, you're already doing something great for your health.
But you may have heard that alkaline water — water that's less acidic than tap water — is even better. Let's investigate whether this is actually true, if alkalized water is really better for health and fitness.
Also, keep in mind that overall body alkalinity isn't always a good thing. For example, if you have a kidney condition, or you're taking a medication that alters kidney function, some of the minerals in alkaline water could start to accumulate in your body. In this case, high alkalinity might lead to negative side effects.
Alkalized water has become all the rage–and it's easy to understand why. Proponents say that alkalized water can boost your metabolism, reduce acid in your bloodstream, and help your body absorb nutrients more quickly, among other benefits. Kangen Water Jalandhar
Kangen Water® is delicious water created from Enagic's innovative water technology. Not only do these devices filter your tap water, but they also produce ionized alkaline and acidic waters through electrolysis. These waters can be used for various purposes, including drinking, cooking, beauty, and cleaning.
Learn more from our website links: Benefits of Alkaline Water, How to get Alkaline Water, Kangen Water. Kangen Water Jalandhar
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WHAT IS ALKALINE WATER Kangen Water Jalandhar
अलकलीन पानी क्या है
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